| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 00855944007772 | EDBU-114-25 | Easy@Home Single Drug Screen Test;25 tests kit; BUP | DJG | Enzyme Immunoassay, Opiates | Easy@Home BUP Single Drug Screen Test (25 tests kit) | ||
| 2 | 00855944007628 | EDCO-114 | EDCO-114-25 | 25 tests kit; COC Single Panel | DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites | Easy@Home COC Single Drug Screen Test (25 tests kit) | |
| 3 | 00850253007833 | EZW2-S | 50 tests kit; LH test strips in bulk package | CEP | Radioimmunoassay, Luteinizing Hormone | Easy@Home Ovulation Test Strip (50 tests-bulk pack) | ||
| 4 | 00855944007369 | EZW-LH3C100 | 100 Disposable Plastic Urine Specimen Cups | CEP | Radioimmunoassay, Luteinizing Hormone | Easy@Home Disposable Plastic Urine Cup (100- pack) | ||
| 5 | 00855944007055 | EZW2-M , EZW1-M | EZM1-L10H2 | Easy@Home 10 Ovulation Test and 2 Pregnancy Test Sticks | CEP,LCX | Radioimmunoassay, Luteinizing Hormone,Kit, Test, Pregnancy, Hcg, Over The Counter | Easy@Home Ovulation Test Kit (10 LH Midstreams+ 2 HCG Midstreams) | |
| 6 | 00850253007840 | EZW1-S | 40 tests kit; HCG strips | Easy@Home Pregnancy Test Strip (40 tests kit) | ||||
| 7 | 00850253007666 | EZM2M3-L10H2 | EZW2-M , EZW1-M | 10 LH midstreams + 2 HCG midstreams | LCX,CEP | Kit, Test, Pregnancy, Hcg, Over The Counter,Radioimmunoassay, Luteinizing Hormone | Easy@Home Ovulation Test Kit (10 LH Midstreams+ 2 HCG Midstreams) | |
| 8 | 00850253007277 | EZW2-S-50 | EZW2-S | CEP | Radioimmunoassay, Luteinizing Hormone | Easy@Home Ovulation Test Strip (50 tests kit) | ||
| 9 | 00850003180250 | EZW1-S; EZW2-S | EZ-WS8020 | Easy@Home Ovulation Test Kit; 80 LH strips + 20 HCG strips | NGE,LCX | Test, Luteinizing Hormone (Lh), Over The Counter,Kit, Test, Pregnancy, Hcg, Over Test, Luteinizing Hormone (Lh), Over The Counter,Kit, Test, Pregnancy, Hcg, Over The Counter | Easy@Home Ovulation Test Kit (80 LH strips + 20 HCG strips ) | |
| 10 | 00810038632988 | ACDOA-754 | ACDOA-754-6 | Areta 5 Panel Drug Test Cup (6 Test Kit) - THC,COC,OPI2000,BZO,AMP | DKZ,DIO,DJG,JXM,LDJ | Enzyme Immunoassay, Amphetamine,Enzyme Immunoassay, Cocaine And Cocaine Metaboli Enzyme Immunoassay, Amphetamine,Enzyme Immunoassay, Cocaine And Cocaine Metabolites,Enzyme Immunoassay, Opiates,Enzyme Immunoassay, Benzodiazepine,Enzyme Immunoassay, Cannabinoids | Areta Multi-Drug Test Cup (6 tests kit) | |
| 11 | 00810038632568 | EBP-08B | EBP-08B | DXN | System, Measurement, Blood-Pressure, Non-Invasive | 2 | Easy@Home Arm Blood Pressure Monitor | |
| 12 | 00810038631400 | EDCO-114 | EDCO-114-25 | 25 tests kit; COC Single Panel | DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites | Easy@Home COC Single Drug Screen Test (25 tests kit) | |
| 13 | 00810038631103 | EHP050 | OCH | Oximeter, Infrared, Sporting, Aviation | 2 | Easy@Home Pulse Oximeter | ||
| 14 | 00810038630373 | EZW1-S | EZW1-S-40 | 40 tests kit; HCG strips | Easy@Home Pregnancy Test Strip (40 tests kit) | |||
| 15 | 00810038630137 | EZW2-S | EZW2-S-50 | 50 tests kit; LH test strips in bulk package | CEP | Radioimmunoassay, Luteinizing Hormone | Easy@Home Ovulation Test Strip (50 tests-bulk pack) | |
| 16 | 00810038632032 | EFM-05R | NUH | Stimulator, Nerve, Transcutaneous, Over-The-Counter | 2 | Easy@Home foot massage mat EFM-05R | ||
| 17 | 00855944007727 | EDOX-114-25 | Easy@Home Single Drug Screen Test; 25 tests kit; OXY | DJG | Enzyme Immunoassay, Opiates | Easy@Home OXY Single Drug Screen Test (25 tests kit) | ||
| 18 | 00855944007604 | ACDOA-1144 | ACDOA-1144-50 | Areta 14-Panel Drug Test Cup (50 Test Kit): AMP,BAR,BUP,BZO,COC,MAMP (MET),MDMA Areta 14-Panel Drug Test Cup (50 Test Kit): AMP,BAR,BUP,BZO,COC,MAMP (MET),MDMA,MTD,OPI2000 (OPI),OXY,PCP,PPX,TCA,THC | DKZ,LDJ,DIO,LAF,CAF,DJG,JXM,LCM,DIS,DJR,LFG,JXN | Enzyme Immunoassay, Amphetamine,Enzyme Immunoassay, Cannabinoids,Enzyme Immunoas Enzyme Immunoassay, Amphetamine,Enzyme Immunoassay, Cannabinoids,Enzyme Immunoassay, Cocaine And Cocaine Metabolites,Gas Chromatography, Methamphetamine,Nebulizer (Direct Patient Interface),Enzyme Immunoassay, Opiates,Enzyme Immunoassay, Benzodiazepine,Enzyme Immunoassay, Phencyclidine,Enzyme Immunoassay, Barbiturate,Enzyme Immunoassay, Methadone,Radioimmunoassay, Tricyclic Antidepressant Drugs,Enzyme Immunoassay, Propoxyphene | Areta Multi-Drug Test Cup (50 tests kit) | |
| 19 | 00855944007161 | EZW1-M | EZM1-H5 | Easy@Home 5 Pregnancy Test Sticks | LCX | Kit, Test, Pregnancy, Hcg, Over The Counter | Easy@Home Pregnancy Test (5 HCG Midstreams ) | |
| 20 | 00855944007574 | ACDOA-6125B | ACDOA-6125B-50 | Areta 12 Panel Drug Test Cup (50 tests kit): BUP,THC,COC,MOP,MET,OXY,AMP,BAR,BZO Areta 12 Panel Drug Test Cup (50 tests kit): BUP,THC,COC,MOP,MET,OXY,AMP,BAR,BZO,MTD,MDMA,PCP | LFG,DJR,DIS,LCM,JXM,DJG,CAF,LAF,DIO,LDJ,DKZ | Radioimmunoassay, Tricyclic Antidepressant Drugs,Enzyme Immunoassay, Methadone,E Radioimmunoassay, Tricyclic Antidepressant Drugs,Enzyme Immunoassay, Methadone,Enzyme Immunoassay, Barbiturate,Enzyme Immunoassay, Phencyclidine,Enzyme Immunoassay, Benzodiazepine,Enzyme Immunoassay, Opiates,Nebulizer (Direct Patient Interface),Gas Chromatography, Methamphetamine,Enzyme Immunoassay, Cocaine And Cocaine Metabolites,Enzyme Immunoassay, Cannabinoids,Enzyme Immunoassay, Amphetamine | Areta Multi-Drug Test Cup (50 tests kit) | |
| 21 | 00855944007543 | ACDOA-754 | ACDOA-754-50 | Areta 5 Panel Drug Test Cup (50 Test Kit) - THC,COC,OPI2000,BZO,AMP | LDJ,JXM,DJG,DIO,DKZ | Enzyme Immunoassay, Cannabinoids,Enzyme Immunoassay, Benzodiazepine,Enzyme Immun Enzyme Immunoassay, Cannabinoids,Enzyme Immunoassay, Benzodiazepine,Enzyme Immunoassay, Opiates,Enzyme Immunoassay, Cocaine And Cocaine Metabolites,Enzyme Immunoassay, Amphetamine | Areta Multi-Drug Test Cup (50 tests kit) | |
| 22 | 00855944007512 | ACDOA-264 | ACDOA-264-50 | Areta 6 Panel Drug Test Cup (50 Test Kit) - AMP, BZO, COC, MAMP (MET), OPI2000 (OPI), THC | LDJ,LAF,JXM,DJG,DIO,DKZ | Enzyme Immunoassay, Cannabinoids,Gas Chromatography, Methamphetamine,Enzyme Immu Enzyme Immunoassay, Cannabinoids,Gas Chromatography, Methamphetamine,Enzyme Immunoassay, Benzodiazepine,Enzyme Immunoassay, Opiates,Enzyme Immunoassay, Cocaine And Cocaine Metabolites,Enzyme Immunoassay, Amphetamine | Areta Multi-Drug Test Cup (50 tests kit) | |
| 23 | 00855944007413 | EDOAP-295 | EDOAP-295-25 | 25 Pack Easy@Home 9 Panel Instant Urine Drug Test - AMP,BUP,BZO,COC,MOP,MTD,OXY,PPX,THC | DKZ,DJG,JXM,DIO,DJR,LDJ,JXN | Enzyme Immunoassay, Amphetamine,Enzyme Immunoassay, Opiates,Enzyme Immunoassay, Enzyme Immunoassay, Amphetamine,Enzyme Immunoassay, Opiates,Enzyme Immunoassay, Benzodiazepine,Enzyme Immunoassay, Cocaine And Cocaine Metabolites,Enzyme Immunoassay, Methadone,Enzyme Immunoassay, Cannabinoids,Enzyme Immunoassay, Propoxyphene | Easy@Home 9 Panel Instant Urine Drug Test (25 test kit) | |
| 24 | 00855944007192 | PM2-C, PM1-C | PMC-3010 | Premom 30 LH Ovulation Cassettes and 10 HCG Pregnancy Cassettes Kit (30 LH + 10 HCG) | CEP,LCX | Radioimmunoassay, Luteinizing Hormone,Kit, Test, Pregnancy, Hcg, Over The Counter | Premom Ovulation Cassette Kit (30 LH + 10 HCG) | |
| 25 | 00855944007178 | PM2-C | PMC-225 | Premom LH Ovulation Cassette (25 Pack of Individually-Sealed LH Urine Tests with Pipette) | CEP | Radioimmunoassay, Luteinizing Hormone | Premom Ovulation Test Cassette (25 test kit) | |
| 26 | 00850253007918 | EDTR-114 | LDJ | Enzyme Immunoassay, Cannabinoids | Easy@Home TRA Single Drug Screen Test (25 tests kit) | |||
| 27 | 00850253007970 | EDOAP-264 | EDOAP-264-15 | 15 tests kit; 6-Panel Dip Card; THC/COC/OPI/AMP/MET/BZO | DKZ,DIO,DJG,JXM,LAF,LDJ | Enzyme Immunoassay, Amphetamine,Enzyme Immunoassay, Cocaine And Cocaine Metaboli Enzyme Immunoassay, Amphetamine,Enzyme Immunoassay, Cocaine And Cocaine Metabolites,Enzyme Immunoassay, Opiates,Enzyme Immunoassay, Benzodiazepine,Gas Chromatography, Methamphetamine,Enzyme Immunoassay, Cannabinoids | Easy@Home Multi-Drug Screen Test (15 tests kit) | |
| 28 | 00850253007895 | EDOAP-144 | 15 tests kit; 4-Panel Dip Card; COC/THC/OPI/MET | LAF,DJG,DIO,LDJ | Gas Chromatography, Methamphetamine,Enzyme Immunoassay, Opiates,Enzyme Immunoass Gas Chromatography, Methamphetamine,Enzyme Immunoassay, Opiates,Enzyme Immunoassay, Cocaine And Cocaine Metabolites,Enzyme Immunoassay, Cannabinoids | Easy@Home Multi-Drug Screen Test (15 tests kit) | ||
| 29 | 00850253007789 | ETP101 | GXY | Electrode, Cutaneous | Easy@Home Self-Adhesive Reusable Electrodes | |||
| 30 | 00850253007765 | EHE016 | NUH | Stimulator, Nerve, Transcutaneous, Over-The-Counter | 2 | Easy@Home Wireless TENS Pulse Massager | ||
| 31 | 00850253007673 | EZM1-H5 | EZW1-M | 5 tests kit; HCG Midstreams | LCX | Kit, Test, Pregnancy, Hcg, Over The Counter | Easy@Home Pregnancy Test (5 HCG Midstreams ) | |
| 32 | 00850253007642 | EZ-WS155 | EZW2-S, EZW1-S | 15 LH strips + 5 HCG strips | LCX,CEP | Kit, Test, Pregnancy, Hcg, Over The Counter,Radioimmunoassay, Luteinizing Hormone | Easy@Home Ovulation Test Kit (15 LH strips + 5 HCG strips ) | |
| 33 | 00850253007505 | EDOAP-1124 | 15 tests kit;12-Panel Dip Card;AMP-COC/OXY-THC/OPI/MET/BZO/MDMA/MTD/BAR/PCP/PPX | JXN,DJR,DIS,LCM,JXM,DJG,CAF,LAF,DIO,LDJ,DKZ | Enzyme Immunoassay, Propoxyphene,Enzyme Immunoassay, Methadone,Enzyme Immunoassa Enzyme Immunoassay, Propoxyphene,Enzyme Immunoassay, Methadone,Enzyme Immunoassay, Barbiturate,Enzyme Immunoassay, Phencyclidine,Enzyme Immunoassay, Benzodiazepine,Enzyme Immunoassay, Opiates,Nebulizer (Direct Patient Interface),Gas Chromatography, Methamphetamine,Enzyme Immunoassay, Cocaine And Cocaine Metabolites,Enzyme Immunoassay, Cannabinoids,Enzyme Immunoassay, Amphetamine | Easy@Home Multi-Drug Screen Test (15 tests kit) | ||
| 34 | 00850253007451 | EDOAP-3104 | 15 tests kit;10-Panel Dip Card;AMP/BAR/BZO/COC/MTD/OPI/MET/THC/PCP/MDMA | DJR,DIS,LCM,JXM,DJG,CAF,LAF,DIO,LDJ,DKZ | Enzyme Immunoassay, Methadone,Enzyme Immunoassay, Barbiturate,Enzyme Immunoassay Enzyme Immunoassay, Methadone,Enzyme Immunoassay, Barbiturate,Enzyme Immunoassay, Phencyclidine,Enzyme Immunoassay, Benzodiazepine,Enzyme Immunoassay, Opiates,Nebulizer (Direct Patient Interface),Gas Chromatography, Methamphetamine,Enzyme Immunoassay, Cocaine And Cocaine Metabolites,Enzyme Immunoassay, Cannabinoids,Enzyme Immunoassay, Amphetamine | Easy@Home Multi-Drug Screen Test (15 tests kit) | ||
| 35 | 00850253007376 | EDOAP-754 | 15 tests kit;5-Panel Dip Card;AMP/BZO/COC/OPI/THC | LDJ,JXM,DJG,DIO,DKZ | Enzyme Immunoassay, Cannabinoids,Enzyme Immunoassay, Benzodiazepine,Enzyme Immun Enzyme Immunoassay, Cannabinoids,Enzyme Immunoassay, Benzodiazepine,Enzyme Immunoassay, Opiates,Enzyme Immunoassay, Cocaine And Cocaine Metabolites,Enzyme Immunoassay, Amphetamine | Easy@Home Multi-Drug Screen Test (15 tests kit) | ||
| 36 | 00850253007321 | EDOAP-254 | 15 tests kit ;5-Panel Dip Card;THC/COC/OPI/AMP/MET | LDJ,LAF,DJG,DIO,DKZ | Enzyme Immunoassay, Cannabinoids,Gas Chromatography, Methamphetamine,Enzyme Immu Enzyme Immunoassay, Cannabinoids,Gas Chromatography, Methamphetamine,Enzyme Immunoassay, Opiates,Enzyme Immunoassay, Cocaine And Cocaine Metabolites,Enzyme Immunoassay, Amphetamine | Easy@Home Multi-Drug Screen Test (15 tests kit) | ||
| 37 | 00850253007192 | EBP-017 | DXN | System, Measurement, Blood-Pressure, Non-Invasive | Easy@Home Wrist Blood Pressure Monitor | |||
| 38 | 00850253007123 | EHE009 | NUH | Stimulator, Nerve, Transcutaneous, Over-The-Counter | Easy@Home TENS Pain Relief Device | |||
| 39 | 00850253007109 | EZD-500A | DQA | Oximeter | Areta Fingertip Pulse Oximeter | |||
| 40 | 00850253007062 | U031-103 | CDM | Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) | Areta 10 Parameters Urinalysis Reagent Strips (100 tests kit） | |||
| 41 | 00810038632445 | EZR-101 | EZR-101-50P | Easy@Home Ketone Test Strips (50 Pack) | JIN | Nitroprusside, Ketones (Urinary, Non-Quant.) | Easy@Home Ketone Test Strips (50 Pack) | |
| 42 | 00810038633930 | EHL038 | ISA | Massager, Therapeutic, Electric | 1 | Easy@Home 2-in-1 Lactation Massager | ||
| 43 | 00810038633473 | EZU-101 | EZU-101-20 | Easy@Home Urinary Tract Infection Test Strips (20 Pack) | LJX,JMT | Test, Urine Leukocyte,Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) | Easy@Home Urinary Tract Infection Test Strips (20 Pack) | |
| 44 | 00810038632018 | EDTH-114 | EDTH-114-20 | 20 tests per kit;THC Single Panel | LDJ | Enzyme Immunoassay, Cannabinoids | Easy@Home Single Drug Screen Test (Cannabinoids Urine Test) (20 tests/kit) | |
| 45 | 00810038630625 | EDOAP-3104 | 5 tests per kit;10-Panel Dip Card; AMP/BAR/BZO/COC/MTD/OPI/MET/THC/PCP/MDMA | DJR,DIS,LCM,JXM,DJG,CAF,LAF,DIO,LDJ,DKZ | Enzyme Immunoassay, Methadone,Enzyme Immunoassay, Barbiturate,Enzyme Immunoassay Enzyme Immunoassay, Methadone,Enzyme Immunoassay, Barbiturate,Enzyme Immunoassay, Phencyclidine,Enzyme Immunoassay, Benzodiazepine,Enzyme Immunoassay, Opiates,Nebulizer (Direct Patient Interface),Gas Chromatography, Methamphetamine,Enzyme Immunoassay, Cocaine And Cocaine Metabolites,Enzyme Immunoassay, Cannabinoids,Enzyme Immunoassay, Amphetamine | Easy@Home Multi-Drug Screen Test (5 tests/kit) | ||
| 46 | 00810038630298 | EZW2-S, EZW1-S | EZ-WS155 | 15 LH strips + 5 HCG strips ; Ovulation Test Kit | CEP,LCX | Radioimmunoassay, Luteinizing Hormone,Kit, Test, Pregnancy, Hcg, Over The Counter | Easy@Home Ovulation Test Kit (15 LH strips + 5 HCG strips ) | |
| 47 | 00810038630113 | EHE009 | NUH | Stimulator, Nerve, Transcutaneous, Over-The-Counter | 2 | Easy@Home TENS Pain Relief Device | ||
| 48 | 00855944007642 | EDTH-114 | EDTH-114-12 | 12 tests kit;THC Single Panel | LDJ | Enzyme Immunoassay, Cannabinoids | Easy@Home THC Single Drug Screen Test (12 tests kit) | |
| 49 | 00855944007482 | EDTH-114 | EDTH-114-6 | 6 tests kit;THC Single Panel | LDJ | Enzyme Immunoassay, Cannabinoids | Easy@Home THC Single Drug Screen Test (6 tests kit) | |
| 50 | 00855944007420 | EHE015 | NUH | Stimulator, Nerve, Transcutaneous, Over-The-Counter | 2 | Easy@Home Mini Wireless TENS Pulse Stimulator |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 00865528000099 | Sensor Model 2017-B | Model 2017-B. The sensor is an accessory device intended for single-patient use Model 2017-B. The sensor is an accessory device intended for single-patient use to assist physicians and patients in recording and monitoring the actuations of prescribed DPI usage for Neohaler® devices.• The Propeller Mobile Application records, stores, and transmits usage events from Propeller Sensors, or via manual user entry, to a remote storage system. With the Propeller Mobile Application the user can review information collected from the DPI sensor, and report and review symptoms and other information about their disease management and its impact. The user may also share their information with their caregivers, physician, and healthcare providers. • The Propeller Web Application is software that, like the Propeller Mobile Application, is intended to allow users to review the collected information and characteristics of their DPI and its use, to capture other patient-reported information and outcomes, and to allow that information to be shared with their caregivers, physicians, and health care providers. • When used with a prescribed DPI, the system can report on information captured during the normal course of use, such as the time between actuations that can be helpful in assessing DPI technique. • The Propeller System is intended to be used in populations from Child (>2 years) to Adult. • The Propeller System can be used both indoors and outdoors; home, work, and clinical settings, as well as on aircraft. • The Propeller System may also be used in clinical trials where researchers need to know information about the use of DPI medication(s) by a participant. • The output of the Propeller System is not intended to diagnose or replace a diagnosis provided by a licensed physician. The Propeller System is not intended for use as an DPI dose counter, nor is it intended to indicate the quantity of medication remaining in an DPI. | Propeller | RECIPROCAL LABS CORPORATION | |
| 2 | 00865528000082 | Sensor Model 2016-M-L | The Propeller System includes the OTC Sensor Model 2016-M for MDI. The sensor is The Propeller System includes the OTC Sensor Model 2016-M for MDI. The sensor is an accessory device intended for single-patient use to assist physicians and patients in recording and monitoring the actuations of prescribed MDI usage.The Propeller Mobile Application records, stores, and transmits usage events from Propeller Sensors, or via manual user entry, to a remote storage system. With the Propeller Mobile Application the user can review information collected from the MDI sensor, and report and review symptoms and other information about their disease management and its impact. The user may also share their information with their caregivers, physician and healthcare providers.The Propeller Web Application is software that, like the Propeller Mobile Application, is intended to allow users to review the collected information and characteristics of their respiratory medication(s) and its use, to capture other patient-reported information and outcomes, and to allow that information to be shared with their caregivers, physicians and healthcare providers.When used with a prescribed MDI, the system can report on information captured during the normal course of use, such as the time between actuations that can be helpful in assessing MDI technique.When used under the care of a physician with a prescribed MDI, or other inhaled medication, the system can be used to reduce the frequency of respiratory health symptoms and exacerbations by increasing adherence to MDI or other inhaled medications through the use of feedback such as reminders and notifications, and self-management education.The Propeller System is intended to be used in populations from Child (>2 years) to adult.The Propeller System can be used both indoors and outdoors; home, work, and clinical settings, as well as on aircraft.The Propeller System may also be used in clinical trials where researchers need to know information about the use of MDI or other inhaled medication(s) by a participant. | Propeller | RECIPROCAL LABS CORPORATION | |
| 3 | 00865528000075 | Sensor Model 2016-M-S | The Propeller System includes the OTC Sensor Model 2016-M for MDI. The sensor is The Propeller System includes the OTC Sensor Model 2016-M for MDI. The sensor is an accessory device intended for single-patient use to assist physicians and patients in recording and monitoring the actuations of prescribed MDI usage.The Propeller Mobile Application records, stores, and transmits usage events from Propeller Sensors, or via manual user entry, to a remote storage system. With the Propeller Mobile Application the user can review information collected from the MDI sensor, and report and review symptoms and other information about their disease management and its impact. The user may also share their information with their caregivers, physician and healthcare providers.The Propeller Web Application is software that, like the Propeller Mobile Application, is intended to allow users to review the collected information and characteristics of their respiratory medication(s) and its use, to capture other patient-reported information and outcomes, and to allow that information to be shared with their caregivers, physicians and healthcare providers.When used with a prescribed MDI, the system can report on information captured during the normal course of use, such as the time between actuations that can be helpful in assessing MDI technique.When used under the care of a physician with a prescribed MDI, or other inhaled medication, the system can be used to reduce the frequency of respiratory health symptoms and exacerbations by increasing adherence to MDI or other inhaled medications through the use of feedback such as reminders and notifications, and self-management education.The Propeller System is intended to be used in populations from Child (>2 years) to adult.The Propeller System can be used both indoors and outdoors; home, work, and clinical settings, as well as on aircraft.The Propeller System may also be used in clinical trials where researchers need to know information about the use of MDI or other inhaled medication(s) by a participant. | Propeller | RECIPROCAL LABS CORPORATION | |
| 4 | 00865528000068 | Sensor Model 2015-E | The Propeller System includes the Propeller Sensor Model 2015-E. The sensor is a The Propeller System includes the Propeller Sensor Model 2015-E. The sensor is an accessory device intended for singlepatientuse to assist physicians and patients in recording and monitoring the actuations of prescribed DPI usage for theEllipta devices.The Propeller Mobile Application records, stores, and transmits usage events from Propeller Sensors, or via manual userentry, to a remote storage system. With the Propeller Mobile Application the user can review information collected fromthe DPI sensor, and report and review symptoms and other information about their disease management and its impact.The user may also share their information with their caregivers, physician, and healthcare providers.The Propeller Web Application is software that, like the Propeller Mobile Application, is intended to allow users toreview the collected information and characteristics of their DPI and its use, to capture other patient-reported informationand outcomes, and to allow that information to be shared with their caregivers, physicians, and health care providers.When used with a prescribed DPI, the system can report on information captured during the normal course of use, such asthe time between actuations that can be helpful in assessing DPI technique.The Propeller System is intended to be used in populations from Child (>2 years) to Adult.The Propeller System can be used both indoors and outdoors; home, work, and clinical settings, as well as on aircraft.The Propeller System may also be used in clinical trials where researchers need to know information about the use of DPImedication(s) by a participant.The output of the Propeller System is not intended to diagnose or replace a diagnosis provided by a licensed physician.The Propeller System is not intended for use as an DPI dose counter, nor is it intended to indicate the quantity ofmedication remaining in an DPI. | Propeller | RECIPROCAL LABS CORPORATION | |
| 5 | 00865528000037 | Sensor Model 2014-D | The Propeller System includes the Propeller DPI Model 2014-D Sensor. The sensor The Propeller System includes the Propeller DPI Model 2014-D Sensor. The sensor is an accessory device intended for single-patient use to assist physicians and patients in recording and monitoring the actuations of prescribed DPI usage.The Propeller Mobile Application records, stores, and transmits usage events from Propeller Sensors, or via manual user entry, to a remote storage system. With the Propeller Mobile Application the user can review information collected from the DPI sensor, and report and review symptoms and other information about their disease management and its impact. The user may also share their information with their caregivers, physician and healthcare providers.The Propeller Web Application is software that, like the Propeller Mobile Application, is intended to allow users to review the collected information and characteristics of their respiratory medication(s) and its use, to capture other patient-reported information and outcomes, and to allow that information to be shared with their caregivers, physicians and healthcare providers.When used with a prescribed DPI, the system can report on information captured during the normal course of use, such as the time between actuations that can be helpful in assessing DPI technique.When used under the care of a physician with a prescribed DPI, or other inhaled medication, the system can be used to reduce the frequency of respiratory health symptoms and exacerbations by increasing adherence to DPI or other inhaled medications through the use of feedback such as reminders and notifications, and self-management education.The Propeller System is intended to be used in populations from Child (>2 years) to adult.The Propeller System can be used both indoors and outdoors; home, work, and clinical settings, as well as on aircraft.The Propeller System may also be used in clinical trials where researchers need to know information about the use of MDI or other inhaled medication(s) by a participant. | Propeller | RECIPROCAL LABS CORPORATION | |
| 6 | 00865528000020 | Sensor Model 2014-R | The Propeller System includes the Propeller SMI Model 2014-R Sensor. The sensor The Propeller System includes the Propeller SMI Model 2014-R Sensor. The sensor is an accessory device intended for single-patient use to assist physicians and patients in recording and monitoring the actuations of prescribed SMI usage.The Propeller Mobile Application records, stores, and transmits usage events from Propeller Sensors, or via manual user entry, to a remote storage system. With the Propeller Mobile Application the user can review information collected from the SMI sensor, and report and review symptoms and other information about their disease management and its impact. The user may also share their information with their caregivers, physician and healthcare providers.The Propeller Web Application is software that, like the Propeller Mobile Application, is intended to allow users to review the collected information and characteristics of their respiratory medication(s) and its use, to capture other patient-reported information and outcomes, and to allow that information to be shared with their caregivers, physicians and healthcare providers.When used with a prescribed SMI, the system can report on information captured during the normal course of use, such as the time between actuations that can be helpful in assessing SMI technique.When used under the care of a physician with a prescribed SMI, or other inhaled medication, the system can be used to reduce the frequency of respiratory health symptoms and exacerbations by increasing adherence to SMI or other inhaled medications through the use of feedback such as reminders and notifications, and self-management education.The Propeller System is intended to be used in populations from Child (>2 years) to adult.The Propeller System can be used both indoors and outdoors; home, work, and clinical settings, as well as on aircraft.The Propeller System may also be used in clinical trials where researchers need to know information about the use of MDI or other inhaled medication(s) by a participant. | Propeller | RECIPROCAL LABS CORPORATION | |
| 7 | 00865528000013 | MDI 2 Sensor | The Propeller System includes the Propeller MDI Model 2 OTC Sensor. The sensor i The Propeller System includes the Propeller MDI Model 2 OTC Sensor. The sensor is an accessory device intended for single-patient use to assist physicians and patients in recording and monitoring the actuations of prescribed MDI usage.The Propeller Mobile Application records, stores, and transmits usage events from Propeller Sensors, or via manual user entry, to a remote storage system. With the Propeller Mobile Application the user can review information collected from the MDI sensor, and report and review symptoms and other information about their disease management and its impact. The user may also share their information with their caregivers, physician and healthcare providers.The Propeller Web Application is software that, like the Propeller Mobile Application, is intended to allow users to review the collected information and characteristics of their respiratory medication(s) and its use, to capture other patient-reported information and outcomes, and to allow that information to be shared with their caregivers, physicians and healthcare providers.When used with a prescribed MDI, the system can report on information captured during the normal course of use, such as the time between actuations that can be helpful in assessing MDI technique.When used under the care of a physician with a prescribed MDI, or other inhaled medication, the system can be used to reduce the frequency of respiratory health symptoms and exacerbations by increasing adherence to MDI or other inhaled medications through the use of feedback such as reminders and notifications, and self-management education.The Propeller System is intended to be used in populations from Child (>2 years) to adult.The Propeller System can be used both indoors and outdoors; home, work, and clinical settings, as well as on aircraft.The Propeller System may also be used in clinical trials where researchers need to know information about the use of MDI or other inhaled medication(s) by a participant. | Propeller | RECIPROCAL LABS CORPORATION | |
| 8 | 00863943000120 | NB40 | Aura Medical | AURA MEDICAL | ||
| 9 | 00863480002113 | 65C12+4 | Status Toxi-Cup 13 panel drug cup with 4 adulterants:AMP1000BAR300COC300THC50MAD Status Toxi-Cup 13 panel drug cup with 4 adulterants:AMP1000BAR300COC300THC50MAD300MET1000MDMA500OPI2000OXY100PCP25TCA1000BUP10 Adulterants - CRE, pH, SG, NBP | Status Toxi Cup 13+4 | LIFESIGN L.L.C. | |
| 10 | 00863480002113 | 65C12+4 | Status Toxi-Cup 13 panel drug cup with 4 adulterants:AMP1000BAR300COC300THC50MAD Status Toxi-Cup 13 panel drug cup with 4 adulterants:AMP1000BAR300COC300THC50MAD300MET1000MDMA500OPI2000OXY100PCP25TCA1000BUP10 Adulterants - CRE, pH, SG, NBP | Status Toxi Cup 13+4 | LIFESIGN L.L.C. | |
| 11 | 00863480002113 | 65C12+4 | Status Toxi-Cup 13 panel drug cup with 4 adulterants:AMP1000BAR300COC300THC50MAD Status Toxi-Cup 13 panel drug cup with 4 adulterants:AMP1000BAR300COC300THC50MAD300MET1000MDMA500OPI2000OXY100PCP25TCA1000BUP10 Adulterants - CRE, pH, SG, NBP | Status Toxi Cup 13+4 | LIFESIGN L.L.C. | |
| 12 | 00863480002113 | 65C12+4 | Status Toxi-Cup 13 panel drug cup with 4 adulterants:AMP1000BAR300COC300THC50MAD Status Toxi-Cup 13 panel drug cup with 4 adulterants:AMP1000BAR300COC300THC50MAD300MET1000MDMA500OPI2000OXY100PCP25TCA1000BUP10 Adulterants - CRE, pH, SG, NBP | Status Toxi Cup 13+4 | LIFESIGN L.L.C. | |
| 13 | 00863480002113 | 65C12+4 | Status Toxi-Cup 13 panel drug cup with 4 adulterants:AMP1000BAR300COC300THC50MAD Status Toxi-Cup 13 panel drug cup with 4 adulterants:AMP1000BAR300COC300THC50MAD300MET1000MDMA500OPI2000OXY100PCP25TCA1000BUP10 Adulterants - CRE, pH, SG, NBP | Status Toxi Cup 13+4 | LIFESIGN L.L.C. | |
| 14 | 00863480002113 | 65C12+4 | Status Toxi-Cup 13 panel drug cup with 4 adulterants:AMP1000BAR300COC300THC50MAD Status Toxi-Cup 13 panel drug cup with 4 adulterants:AMP1000BAR300COC300THC50MAD300MET1000MDMA500OPI2000OXY100PCP25TCA1000BUP10 Adulterants - CRE, pH, SG, NBP | Status Toxi Cup 13+4 | LIFESIGN L.L.C. | |
| 15 | 00863480002113 | 65C12+4 | Status Toxi-Cup 13 panel drug cup with 4 adulterants:AMP1000BAR300COC300THC50MAD Status Toxi-Cup 13 panel drug cup with 4 adulterants:AMP1000BAR300COC300THC50MAD300MET1000MDMA500OPI2000OXY100PCP25TCA1000BUP10 Adulterants - CRE, pH, SG, NBP | Status Toxi Cup 13+4 | LIFESIGN L.L.C. | |
| 16 | 00863480002106 | 60B02 | LifeSign QuikScreen 11: Amphetamine (AMP) 1000 ng/mlPhencyclidine (PCP) 25 ng/ml LifeSign QuikScreen 11: Amphetamine (AMP) 1000 ng/mlPhencyclidine (PCP) 25 ng/mlMethamphetamine (MET) 1000 ng/mlOpiate (OPI) 2000 ng/mlBarbiturates (BAR) 300 ng/mlBenzodiazepine (BZD) 300 ng/mlMarijuana (THC) 50 ng/mlMethadone (MAD) 300 ng/mlOxycodone (OXY) 100 ng/mlTricyclic Antidepressants (TCA) 1000 ng/mlCocaine (COC) 300ng/ml | LifeSign QuikScreen 11 | LIFESIGN L.L.C. | |
| 17 | 00863480002106 | 60B02 | LifeSign QuikScreen 11: Amphetamine (AMP) 1000 ng/mlPhencyclidine (PCP) 25 ng/ml LifeSign QuikScreen 11: Amphetamine (AMP) 1000 ng/mlPhencyclidine (PCP) 25 ng/mlMethamphetamine (MET) 1000 ng/mlOpiate (OPI) 2000 ng/mlBarbiturates (BAR) 300 ng/mlBenzodiazepine (BZD) 300 ng/mlMarijuana (THC) 50 ng/mlMethadone (MAD) 300 ng/mlOxycodone (OXY) 100 ng/mlTricyclic Antidepressants (TCA) 1000 ng/mlCocaine (COC) 300ng/ml | LifeSign QuikScreen 11 | LIFESIGN L.L.C. | |
| 18 | 00863480002106 | 60B02 | LifeSign QuikScreen 11: Amphetamine (AMP) 1000 ng/mlPhencyclidine (PCP) 25 ng/ml LifeSign QuikScreen 11: Amphetamine (AMP) 1000 ng/mlPhencyclidine (PCP) 25 ng/mlMethamphetamine (MET) 1000 ng/mlOpiate (OPI) 2000 ng/mlBarbiturates (BAR) 300 ng/mlBenzodiazepine (BZD) 300 ng/mlMarijuana (THC) 50 ng/mlMethadone (MAD) 300 ng/mlOxycodone (OXY) 100 ng/mlTricyclic Antidepressants (TCA) 1000 ng/mlCocaine (COC) 300ng/ml | LifeSign QuikScreen 11 | LIFESIGN L.L.C. | |
| 19 | 00863480002106 | 60B02 | LifeSign QuikScreen 11: Amphetamine (AMP) 1000 ng/mlPhencyclidine (PCP) 25 ng/ml LifeSign QuikScreen 11: Amphetamine (AMP) 1000 ng/mlPhencyclidine (PCP) 25 ng/mlMethamphetamine (MET) 1000 ng/mlOpiate (OPI) 2000 ng/mlBarbiturates (BAR) 300 ng/mlBenzodiazepine (BZD) 300 ng/mlMarijuana (THC) 50 ng/mlMethadone (MAD) 300 ng/mlOxycodone (OXY) 100 ng/mlTricyclic Antidepressants (TCA) 1000 ng/mlCocaine (COC) 300ng/ml | LifeSign QuikScreen 11 | LIFESIGN L.L.C. | |
| 20 | 00863480002106 | 60B02 | LifeSign QuikScreen 11: Amphetamine (AMP) 1000 ng/mlPhencyclidine (PCP) 25 ng/ml LifeSign QuikScreen 11: Amphetamine (AMP) 1000 ng/mlPhencyclidine (PCP) 25 ng/mlMethamphetamine (MET) 1000 ng/mlOpiate (OPI) 2000 ng/mlBarbiturates (BAR) 300 ng/mlBenzodiazepine (BZD) 300 ng/mlMarijuana (THC) 50 ng/mlMethadone (MAD) 300 ng/mlOxycodone (OXY) 100 ng/mlTricyclic Antidepressants (TCA) 1000 ng/mlCocaine (COC) 300ng/ml | LifeSign QuikScreen 11 | LIFESIGN L.L.C. | |
| 21 | 00863480002106 | 60B02 | LifeSign QuikScreen 11: Amphetamine (AMP) 1000 ng/mlPhencyclidine (PCP) 25 ng/ml LifeSign QuikScreen 11: Amphetamine (AMP) 1000 ng/mlPhencyclidine (PCP) 25 ng/mlMethamphetamine (MET) 1000 ng/mlOpiate (OPI) 2000 ng/mlBarbiturates (BAR) 300 ng/mlBenzodiazepine (BZD) 300 ng/mlMarijuana (THC) 50 ng/mlMethadone (MAD) 300 ng/mlOxycodone (OXY) 100 ng/mlTricyclic Antidepressants (TCA) 1000 ng/mlCocaine (COC) 300ng/ml | LifeSign QuikScreen 11 | LIFESIGN L.L.C. | |
| 22 | 00863480002106 | 60B02 | LifeSign QuikScreen 11: Amphetamine (AMP) 1000 ng/mlPhencyclidine (PCP) 25 ng/ml LifeSign QuikScreen 11: Amphetamine (AMP) 1000 ng/mlPhencyclidine (PCP) 25 ng/mlMethamphetamine (MET) 1000 ng/mlOpiate (OPI) 2000 ng/mlBarbiturates (BAR) 300 ng/mlBenzodiazepine (BZD) 300 ng/mlMarijuana (THC) 50 ng/mlMethadone (MAD) 300 ng/mlOxycodone (OXY) 100 ng/mlTricyclic Antidepressants (TCA) 1000 ng/mlCocaine (COC) 300ng/ml | LifeSign QuikScreen 11 | LIFESIGN L.L.C. | |
| 23 | 00863112000364 | CI-575 | CI-575 | 7-Panel T-Cup; AMP/BZO/COC/MET/MOP/OXY/THC | BioTech Screening | BIOTECH SCREENING LLC |
| 24 | 00863112000364 | CI-575 | CI-575 | 7-Panel T-Cup; AMP/BZO/COC/MET/MOP/OXY/THC | BioTech Screening | BIOTECH SCREENING LLC |
| 25 | 00863112000364 | CI-575 | CI-575 | 7-Panel T-Cup; AMP/BZO/COC/MET/MOP/OXY/THC | BioTech Screening | BIOTECH SCREENING LLC |
| 26 | 00863112000364 | CI-575 | CI-575 | 7-Panel T-Cup; AMP/BZO/COC/MET/MOP/OXY/THC | BioTech Screening | BIOTECH SCREENING LLC |
| 27 | 00863112000364 | CI-575 | CI-575 | 7-Panel T-Cup; AMP/BZO/COC/MET/MOP/OXY/THC | BioTech Screening | BIOTECH SCREENING LLC |
| 28 | 00863112000364 | CI-575 | CI-575 | 7-Panel T-Cup; AMP/BZO/COC/MET/MOP/OXY/THC | BioTech Screening | BIOTECH SCREENING LLC |
| 29 | 00863112000326 | CINM-774 | CINM-774 | 7-Panel T-Cup; AMP/MET/BZO/BUP/COC/OPI/THC | BioTech Screening | BIOTECH SCREENING LLC |
| 30 | 00863112000326 | CINM-774 | CINM-774 | 7-Panel T-Cup; AMP/MET/BZO/BUP/COC/OPI/THC | BioTech Screening | BIOTECH SCREENING LLC |
| 31 | 00863112000326 | CINM-774 | CINM-774 | 7-Panel T-Cup; AMP/MET/BZO/BUP/COC/OPI/THC | BioTech Screening | BIOTECH SCREENING LLC |
| 32 | 00863112000326 | CINM-774 | CINM-774 | 7-Panel T-Cup; AMP/MET/BZO/BUP/COC/OPI/THC | BioTech Screening | BIOTECH SCREENING LLC |
| 33 | 00863112000326 | CINM-774 | CINM-774 | 7-Panel T-Cup; AMP/MET/BZO/BUP/COC/OPI/THC | BioTech Screening | BIOTECH SCREENING LLC |
| 34 | 00863112000326 | CINM-774 | CINM-774 | 7-Panel T-Cup; AMP/MET/BZO/BUP/COC/OPI/THC | BioTech Screening | BIOTECH SCREENING LLC |
| 35 | 00863112000319 | CINM-274 | CINM-274 | 7-Panel T-Cup; COC/OXY/BZO/OPI/MET/AMP/THC | BioTech Screening | BIOTECH SCREENING LLC |
| 36 | 00863112000319 | CINM-274 | CINM-274 | 7-Panel T-Cup; COC/OXY/BZO/OPI/MET/AMP/THC | BioTech Screening | BIOTECH SCREENING LLC |
| 37 | 00863112000319 | CINM-274 | CINM-274 | 7-Panel T-Cup; COC/OXY/BZO/OPI/MET/AMP/THC | BioTech Screening | BIOTECH SCREENING LLC |
| 38 | 00863112000319 | CINM-274 | CINM-274 | 7-Panel T-Cup; COC/OXY/BZO/OPI/MET/AMP/THC | BioTech Screening | BIOTECH SCREENING LLC |
| 39 | 00863112000319 | CINM-274 | CINM-274 | 7-Panel T-Cup; COC/OXY/BZO/OPI/MET/AMP/THC | BioTech Screening | BIOTECH SCREENING LLC |
| 40 | 00863112000319 | CINM-274 | CINM-274 | 7-Panel T-Cup; COC/OXY/BZO/OPI/MET/AMP/THC | BioTech Screening | BIOTECH SCREENING LLC |
| 41 | 00863112000302 | CI-565 | CI-565 | 6-Panel T-Cup; AMP/BZO/COC/MET/MOP/OXY | BioTech Screening | BIOTECH SCREENING LLC |
| 42 | 00863112000302 | CI-565 | CI-565 | 6-Panel T-Cup; AMP/BZO/COC/MET/MOP/OXY | BioTech Screening | BIOTECH SCREENING LLC |
| 43 | 00863112000302 | CI-565 | CI-565 | 6-Panel T-Cup; AMP/BZO/COC/MET/MOP/OXY | BioTech Screening | BIOTECH SCREENING LLC |
| 44 | 00863112000302 | CI-565 | CI-565 | 6-Panel T-Cup; AMP/BZO/COC/MET/MOP/OXY | BioTech Screening | BIOTECH SCREENING LLC |
| 45 | 00863112000302 | CI-565 | CI-565 | 6-Panel T-Cup; AMP/BZO/COC/MET/MOP/OXY | BioTech Screening | BIOTECH SCREENING LLC |
| 46 | 00861272000392 | ALLTHCR | 1 Panel urine cup that tests for THC (Marijuana) which includes a Lab Confirmation. | AllSource Screening Solutions - Drug Detector | ALLSOURCE SCREENING SOLUTIONS, LLC | |
| 47 | 00861272000385 | ALL8145R | 14 Panel urine cup that tests for (THC-COC150-MOP-AMP500-MET500-PCP-BZO-BAR-MDMA 14 Panel urine cup that tests for (THC-COC150-MOP-AMP500-MET500-PCP-BZO-BAR-MDMA-MTD-OXY-BUP-TCA-EDDP) which includes a Lab Confirmation. | AllSource Screening Solutions - Drug Detector | ALLSOURCE SCREENING SOLUTIONS, LLC | |
| 48 | 00861272000378 | ALL254R | 5 Panel urine cup that tests for (THC-COC-OPI-AMP-MET) which includes a Lab Confirmation. | AllSource Screening Solutions - Drug Detector | ALLSOURCE SCREENING SOLUTIONS, LLC | |
| 49 | 00861272000361 | ALLTHCR | 1 Panel urine cup that tests for THC (Marijuana) which includes a Lab Confirmation. | AllSource Screening Solutions - Drug Detector | ALLSOURCE SCREENING SOLUTIONS, LLC | |
| 50 | 00861272000354 | ALL254R | 5 Panel urine cup that tests for (THC-COC-OPI-AMP-MET) which includes a Lab Confirmation. | AllSource Screening Solutions - Drug Detector | ALLSOURCE SCREENING SOLUTIONS, LLC |