No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00681131895408 | HEM-741CRELN4 | DXN | System, Measurement, Blood-Pressure, Non-Invasive | Relion BP200 Upper Arm Blood Pressure Monitor | |||
2 | 00681131130332 | 700025 | Blood Glucose Test Strips | CGA | GLUCOSE OXIDASE, GLUCOSE | ReliOn® Prime Blood Glucose Test Strips | ||
3 | 00605388780065 | 780006 | ReliOn Premier Control Solution Level 2 contains a known amount of glucose that ReliOn Premier Control Solution Level 2 contains a known amount of glucose that reacts with the test strips and is used to check if the meter and test strips are working correctly as a system and you are testing correctly. Compare the control solution test result with the range printed on the test strip bottle label. (Primary UPC# 605388780065 is used as the assigned UDI for the Class I device.) | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | ReliOn™ Premier Control Solution Level 2 | |
4 | 00605388780058 | 780005 | ReliOn Premier Control Solution Level 1 contains a known amount of glucose that ReliOn Premier Control Solution Level 1 contains a known amount of glucose that reacts with the test strips and is used to check if the meter and test strips are working correctly as a system and you are testing correctly. Compare the control solution test result with the range printed on the test strip bottle label. (Primary UPC# 605388780058 is used as the assigned UDI for the Class I device.) | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | ReliOn™ Premier Control Solution Level 1 | |
5 | 00605388577221 | 6021RELN2 | DXN | System, Measurement, Blood-Pressure, Non-Invasive | ReliOn BP300W Wrist Blood Pressure Monitor | |||
6 | 00605388022943 | 700050 / 700100 | Blood Glucose Test Strips | CGA | GLUCOSE OXIDASE, GLUCOSE | ReliOn® Prime Blood Glucose Test Strips | ||
7 | 04897074551752 | EQ3105-UL | KFZ | Humidifier, Non-Direct Patient Interface (Home-Use) | 1 | Equate | ||
8 | 00605388043863 | BP3UP1-1ARL | DXN | System, Measurement, Blood-Pressure, Non-Invasive | 2 | ReliOn | ||
9 | 04897074551462 | EQ2109-UL | KFZ | Humidifier, Non-Direct Patient Interface (Home-Use) | 1 | Equate | ||
10 | 00681131403399 | 09556729001 | RELION PLATINUM KIT MG/DL | NBW | System, Test, Blood Glucose, Over The Counter | 2 | RELION | |
11 | 00681131403283 | 09409963001 | RELION PLATINUM 100CT STRIPS | NBW | System, Test, Blood Glucose, Over The Counter | 2 | RELION | |
12 | 00681131403276 | 09409971001 | RELION PLATINUM 50CT STRIPS | NBW | System, Test, Blood Glucose, Over The Counter | 2 | RELION | |
13 | 00681131403252 | 3055 | 3055 | The ReliOn A1C Self Test System provides a quantitative measurement of the perce The ReliOn A1C Self Test System provides a quantitative measurement of the percent of glycated hemoglobin levels in capillary (fingerstick) blood samples. The test is for home use to monitor glycemic control in people with diabetes. | LCP | Assay, Glycosylated Hemoglobin | ReliOn™ 2CT A1C Meter | |
14 | 00681131247887 | 8500 Series | UA-8500WM | Upper Arm Premium Digital Blood Pressure Monitor | DXN | System, Measurement, Blood-Pressure, Non-Invasive | 2 | Equate Premium BP Monitor |
15 | 00681131240727 | 783110 | The ReliOn Premier Compact Blood Glucose Monitoring System is intended for the q The ReliOn Premier Compact Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in freshcapillary whole blood samples drawn from the fingertips and alternative sites such as the forearm, palm, thigh and calf.Carton contains: ReliOn Premier Compact Meter DI# 30681131240728, ReliOn Premier Test Strips 50ct DI# 00681131169776, Lancing Device, Lancets and Literature. | NBW | System, Test, Blood Glucose, Over The Counter | 2 | ReliOn™ Premier Compact Blood Glucose Monitoring System | |
16 | 00681131175982 | One Step Pregnancy Test | FHC-102H Walmart First Signal Preg Cassette | LCX | Kit, Test, Pregnancy, Hcg, Over The Counter | 2 | Equate First Signal | |
17 | 00681131169851 | 780001 | The ReliOn Premier Voice Blood Glucose Monitoring System is intended for the qua The ReliOn Premier Voice Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips and alternative sites such as the forearm, palm, thigh and calf. | JJX,CGA,NBW | Single (Specified) Analyte Controls (Assayed And Unassayed),Glucose Oxidase, Glu Single (Specified) Analyte Controls (Assayed And Unassayed),Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter | 1 | ReliOn™ Premier Voice Basic Meter | |
18 | 00681131062756 | 144-920-000 | 144-920-000 | RELION 20 SEC THERMOMETER FLEX TIP DIGITAL STICK | FLL | Thermometer, Electronic, Clinical | 2 | RELION |
19 | 00681131060271 | 144-639-000 | 144-639-000 | RELION BASAL DIGITAL THERM | OZK | Thermometer, Exhaled Breath | 2 | RELION |
20 | 00681131060264 | 144-621-000 | 144-621-000 | RELION DIGITAL PROBE COVERS ORAL 30/PER PACK 24/CASE | FLL | Thermometer, Electronic, Clinical | 2 | RELION |
21 | 00681131060240 | 144-691-000 | 144-691-000 | RELION 60 SEC DIG THERM W/BEEPER FAHRE IN BOX | FLL | Thermometer, Electronic, Clinical | 2 | RELION |
22 | 00605388860170 | 712020 | Blood Glucose Test Strips | CGA | GLUCOSE OXIDASE, GLUCOSE | ReliOn® Confirm/micro Blood Glucose Test Strips | ||
23 | 00605388878113 | 100-021REL | 004017283 | Self Taking Blood Pressure Kit | DXQ | Blood Pressure Cuff | RELION | |
24 | 00605388710055 | 710005 | ReliOn Confirm/Micro Control contains a known amount of glucose that reacts with ReliOn Confirm/Micro Control contains a known amount of glucose that reacts with the test strips and is used to check if the meter and test strips are working correctly. Compare the control solution test result with the range printed on the test strip bottle. | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | ReliOn™ Confirm/Micro Control | |
25 | 00605388564474 | 710050 / 712100 | Blood Glucose Test Strips | CGA | GLUCOSE OXIDASE, GLUCOSE | ReliOn® Confirm/micro Blood Glucose Test Strips | ||
26 | 00365702701212 | 09397051001 | IWL ReliOn meter 982 mg/dl US | NBW | System, Test, Blood Glucose, Over The Counter | 2 | RELION | |
27 | 00078742257730 | 31G x 5 mm | 8931 | Sterile, single use pen needles.Intended to be used with pen injector device for Sterile, single use pen needles.Intended to be used with pen injector device for the subcutaneous injection of insulin. | FMI | Needle, Hypodermic, Single Lumen | Member's Mark pen needles 31G 5mm | |
28 | 00078742168739 | 94213 | 94213 | MEMBERS MARK MPS 3X480ML | LPN | Accessories, soft lens products | 2 | MEMBERS MARK |
29 | 00078742092751 | 94106HZ | 94106HZ | MEMBERS MARK MPS 3X480ML | LPN | ACCESSORIES, SOFT LENS PRODUCTS | 2 | MEMBERS MARK |
30 | 00681131972178 | 571238492 | EVERYDAY LINER LONG UNSCENTED 108 CT | HHD | Pad, Menstrual, Unscented | EQUATE | ||
31 | 00681131972154 | 269822 | ULTRA THIN PADS WINGS LONG SUPER UNSCENTED 32CT | HHD | Pad, Menstrual, Unscented | EQUATE | ||
32 | 00681131972147 | 269804 | ULTRA THIN PADS WINGS REGULAR UNSCENTED 36 CT | HHD | Pad, Menstrual, Unscented | EQUATE | ||
33 | 00681131864886 | 591631344 | ULTRA THIN PADS WINGS LONG OVERNIGHT UNSCENTED 28CT | HHD | Pad, Menstrual, Unscented | EQUATE | ||
34 | 00681131864800 | 272989 | MAXI PADS SUPER UNSCENTED 48 CT | HHD | Pad, Menstrual, Unscented | 1 | EQUATE | |
35 | 00681131423151 | 594855380 | ULTRA THIN PADS WINGS EXTRA HEAVY OVERNIGHT SUPER UNSCENTED 46 CT | HHD | Pad, Menstrual, Unscented | EQUATE | ||
36 | 00681131423144 | 587326752 | MAXI PADS WINGS EXTRA HEAVY OVERNIGHT UNSCENTED 36 CT | HHD | Pad, Menstrual, Unscented | EQUATE | ||
37 | 00681131240635 | 569811747 | MAXI PADS WINGS OVERNIGHT UNSCENTED 26 CT | HHD | Pad, Menstrual, Unscented | EQUATE | ||
38 | 00681131297776 | 4048645 | EQUATE PERSONAL LUBRICANT 5 OZ - (WM-091-5OZ) | NUC | Lubricant, Personal | 2 | EQUATE | |
39 | 00681131248938 | SC-206 | CONTACT LENS CASE, 1 PACK | LRX | Case, Contact Lens | 2 | EQUATE | |
40 | 00681131248914 | SC-110 | FLIP TOP CONTACT LENS CASE, 1 PACK | LRX | Case, Contact Lens | 2 | EQUATE | |
41 | 00681131247863 | 6000 Series | UA-6000WM | Upper Arm Digital Blood Pressure Monitor | DXN | System, Measurement, Blood-Pressure, Non-Invasive | 2 | Equate Advanced BP Monitor |
42 | 00681131240666 | 569811748 | ULTRA THIN PADS WINGS LONG SUPER UNSCENTED 42CT | HHD | Pad, Menstrual, Unscented | EQUATE | ||
43 | 00681131240659 | 570641219 | MAXI PADS WINGS EXTRA LONG SUPER UNSCENTED 42 CT | HHD | Pad, Menstrual, Unscented | EQUATE | ||
44 | 00681131240642 | 570641221 | MAXI PADS WINGS REGULAR UNSCENTED 45 CT | HHD | Pad, Menstrual, Unscented | EQUATE | ||
45 | 00681131234160 | 567043998 | ULTRA THIN PADS WINGS EXTRA HEAVY OVERNIGHT SUPER UNSCENTED 34 CT | HHD | Pad, Menstrual, Unscented | 1 | EQUATE | |
46 | 00681131173933 | 565182712 | MAXI PADS WINGS EXTRA LONG SUPER UNSCENTED 26 CT | HHD | Pad, Menstrual, Unscented | EQUATE | ||
47 | 00681131173926 | 565182760 | ULTRA THIN PADS WINGS EXTRA LONG SUPER UNSCENTED 28 CT | HHD | Pad, Menstrual, Unscented | EQUATE | ||
48 | 00681131136075 | 563004770 | ULTRA THIN PADS WINGS LONG OVERNIGHT UNSCENTED 28CT | HHD | Pad, Menstrual, Unscented | EQUATE | ||
49 | 00681131108454 | 573515526 | EVERYDAY LINER EXTRA COVERAGE LONG UNSCENTED 68 CT | HHD | Pad, Menstrual, Unscented | EQUATE | ||
50 | 00681131104821 | 563004771 | ULTRA THIN PADS WINGS LONG OVERNIGHT UNSCENTED 14CT | HHD | Pad, Menstrual, Unscented | EQUATE |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 09351337000081 | GM-700O | Ovulation test | GENERATION GUARD PTY LTD | ||
2 | 09351337000074 | GM-700P | Pregnancy test | GENERATION GUARD PTY LTD | ||
3 | 09351337000029 | GM-700PO | Ovulation and Pregnancy test Kit | GENERATION GUARD PTY LTD | ||
4 | 08809408860597 | HCGS003E | Surearly™ Pregnancy Test Strip is a strip coated with reagents. One end of the s Surearly™ Pregnancy Test Strip is a strip coated with reagents. One end of the strip is a sample pad for urine dipping, and the control and test regions are located in the middle of the strip. Users immerse the sample pad of the strip into the collected urine and see the test results from the colored lines appeared on the strip. The test results are interpreted by users according to the instructions for use. | Surearly™ Pregnancy Test Strip | SUGENTECH INC._OSONG BRANCH | |
5 | 08809408860191 | SU-DR02-CG | HCGR001E | Surearly™ Digital Pregnancy Test is a digital test reader with a LCD display, co Surearly™ Digital Pregnancy Test is a digital test reader with a LCD display, combining with an absorbent tip covered by a plastic cap. The absorbent tip that protrudes from the end of the test reader absorbs and delivers urine to reagents on a RAPID type test strip which is located inside a plastic housing of the device. The test reader is automatically switched on, by removing the power film located at the grip. The absorbent tip is placed in urine stream directly or alternatively immersed into the collected urine. The test reader detects the colored lines and shows the digital test result on the display. | Surearly™ Digital Pregnancy Test | SUGENTECH INC._OSONG BRANCH |
6 | 08719699634633 | FK-127-CO | FK-127A contains 50 ovulation test and 20 pregnancy tests. | iProven | SEVENGROUND TRADING B.V. | |
7 | 08719699633254 | FMH-139-3 | FMH-139 is a One Step HCG Urine Pregnancy Test | iProven | SEVENGROUND TRADING B.V. | |
8 | 08719699633230 | FMH-139-5 | FMH-139 is a One Step HCG Urine Pregnancy Test | iProven | SEVENGROUND TRADING B.V. | |
9 | 08719699630901 | FMH-139-5 | FMH-139 is a One Step HCG Urine Pregnancy Test | iProven | SEVENGROUND TRADING B.V. | |
10 | 08719481722043 | FMH-139-5 | Box with five midstream pregnancy tests | iProvèn | MASENA INVEST B.V. | |
11 | 08719481722029 | FMH-139-3 | Box with three midstream pregnancy tests | iProvèn | MASENA INVEST B.V. | |
12 | 08719481721077 | FK-127s-A | Fertility KIT with 30 teststrips | iProvèn | MASENA INVEST B.V. | |
13 | 08719481721046 | FH-30-HCG-A | Box with 30 pregnancy teststrips | iProvèn | MASENA INVEST B.V. | |
14 | 08719481720865 | FK-127-A | Fertility KIT with 70 teststrips | iProvèn | MASENA INVEST B.V. | |
15 | 08719481720759 | FH-30 | Box with 30 pregnancy teststrips | iProvèn | MASENA INVEST B.V. | |
16 | 08719481720728 | FK-127s | Box with 25 ovulation teststrips and 5 pregnancy teststrips | iProvèn | MASENA INVEST B.V. | |
17 | 08719481720179 | FK-127-W-HCGtest | HCG strips - pregnancy test strips - REGISTRATION NUMBER HCG STRIP: 21 CFR 862.1155 | iProvèn | MASENA INVEST B.V. | |
18 | 08719481720162 | FK-127-HCGtest | HCG strips - pregnancy test strips | iProvèn | MASENA INVEST B.V. | |
19 | 07350014630209 | 20 | Plan-a-pregnancy kit with Natural Cycles 6 month subscription, a basal thermomet Plan-a-pregnancy kit with Natural Cycles 6 month subscription, a basal thermometer, 10 ovulation strip tests and 5 pregnancy strip tests. | Natural Cycles | NATURALCYCLES NORDIC AB | |
20 | 07350014630155 | 15 | Test, Pregnancy, Hcg, Over The Counter | Natural Cycles | NATURALCYCLES NORDIC AB | |
21 | 06974464590084 | 0741M4X003 | One Step HCG Urine Test Midstream | MissLan | GUANGZHOU DECHENG BIOTECHNOLOGY CO., LTD | |
22 | 06974464590053 | 0741M4X002 | LH and HCG combo test midstream | MissLan | GUANGZHOU DECHENG BIOTECHNOLOGY CO., LTD | |
23 | 06974464590046 | 0741M4X005 | LH and HCG combo test midstream | MissLan | GUANGZHOU DECHENG BIOTECHNOLOGY CO., LTD | |
24 | 06974464590039 | 0731S3X020 | LH and HCG combo test strip | MissLan | GUANGZHOU DECHENG BIOTECHNOLOGY CO., LTD | |
25 | 06970429840300 | HCG Cassette | Co-innovation | CO-INNOVATION BIOTECH CO., LTD | ||
26 | 06970429840164 | 1 | HCG TEST | PREGABLE | CO-INNOVATION BIOTECH CO., LTD | |
27 | 06970429840157 | HCG3.5 | HCG TEST STRIP | CO-INNOVATION BIOTECH CO., LTD | ||
28 | 06970429840133 | HCG Test Strip | HealthyWiser | CO-INNOVATION BIOTECH CO., LTD | ||
29 | 06970429840126 | HCG Pregnancy Test | HCG Pregnancy Test Strip | AICARE | CO-INNOVATION BIOTECH CO., LTD | |
30 | 06970429840119 | HCG TEST STRIP | HCG TEST STRIP | MomMed | CO-INNOVATION BIOTECH CO., LTD | |
31 | 06970429840102 | HCG Strip/4.0mm | Co-innovation | CO-INNOVATION BIOTECH CO., LTD | ||
32 | 06970277512404 | FHC-103H | FHC-103H | Pregnancy (hCG) Rapid Test Midstream | Pregnancy (hCG) Rapid Test Midstream | HANGZHOU ALLTEST BIOTECH CO., LTD. |
33 | 06942820412332 | HCG (2.0) | One Step HCG Urine Pregnancy Test Strip | ChoiceMMed | BEIJING CHOICE ELECTRONIC TECHNOLOGY CO., LTD. | |
34 | 06938444985017 | 11C-1867-U | RH-HCG-B | LotFancy Pregnancy Test is a self-testing immunoassay designed for the qualitati LotFancy Pregnancy Test is a self-testing immunoassay designed for the qualitative determination of human chorionic gonadotropin (hCG) in the urine to aid in early detection of pregnancy. There are 25pcs of 2.5mm strips in each box. | LotFancy | RUNBIO BIOTECH CO., LTD. |
35 | 06938444982641 | 82641 | DAVID Ovulation & Pregnancy Test Kit is consisiting of 40 ovulation test strips, DAVID Ovulation & Pregnancy Test Kit is consisiting of 40 ovulation test strips, 10 pregnancy test strips and 2 pregnancy crystal tests. | DAVID | RUNBIO BIOTECH CO., LTD. | |
36 | 06938444982610 | 82610 | DAVID Pregnancy Test is intended for the qualitative determination of human chor DAVID Pregnancy Test is intended for the qualitative determination of human chorionic gonadotropin (hCG) in the urine to aid in early detection of pregnancy. There are 6 ctrystal strips and 10 regular strips in one box.. | DAVID | RUNBIO BIOTECH CO., LTD. | |
37 | 06938444982603 | 82603 | DAVID Ovulation & Pregnancy Test is consisiting of 90 ovulation test strips and DAVID Ovulation & Pregnancy Test is consisiting of 90 ovulation test strips and 30 pregnancy test strips . | DAVID | RUNBIO BIOTECH CO., LTD. | |
38 | 06938444982382 | 82382 | RH-HCG10-B | DAVID Pregnancy Test is intended for the qualitative determination of human chor DAVID Pregnancy Test is intended for the qualitative determination of human chorionic gonadotropin (hCG) in the urine to aid in early detection of pregnancy. There are 2 midstreams in one box. | DAVID Pregnancy Test | RUNBIO BIOTECH CO., LTD. |
39 | 06938444982375 | 82375 | DAVID Pregnancy Test is intended for the qualitative determination of human chor DAVID Pregnancy Test is intended for the qualitative determination of human chorionic gonadotropin (hCG) in the urine to aid in early detection of pregnancy. There are 25 strips in one box. | DAVID Pregnancy Test | RUNBIO BIOTECH CO., LTD. | |
40 | 06938444982368 | 82368 | DAVID Pregnancy Test is intended for the qualitative determination of human chor DAVID Pregnancy Test is intended for the qualitative determination of human chorionic gonadotropin (hCG) in the urine to aid in early detection of pregnancy. There are 10 strips in one box. | DAVID Pregnancy Test | RUNBIO BIOTECH CO., LTD. | |
41 | 06938444982269 | 82269 | This product is intended for the qualitative determination of human chorionic go This product is intended for the qualitative determination of human chorionic gonadotropin (hCG) in the urine to aid in early detection of pregnancy. There are 3 strips and 3 midstreams in one box. | DAVID | RUNBIO BIOTECH CO., LTD. | |
42 | 06938444982245 | 82245 | This product is intended for the qualitative determination of human chorionic go This product is intended for the qualitative determination of human chorionic gonadotropin (hCG) in the urine to aid in early detection of pregnancy. There are 3 midstreams in one box. | SUUCARE | RUNBIO BIOTECH CO., LTD. | |
43 | 06938444982207 | 82207 | 6 days Ahead Pregnancy Test (3 HCG Midstreams) is intended for the qualitative d 6 days Ahead Pregnancy Test (3 HCG Midstreams) is intended for the qualitative determination of human chorionic gonadotropin (hCG) in the urine to aid in early detection of pregnancy. | 6 days Ahead Pregnancy Test (3 HCG Midstreams) | RUNBIO BIOTECH CO., LTD. | |
44 | 06938444982191 | 82191 | Early Blush Pregnancy Test (3 HCG Midstreams) is intended for the qualitative de Early Blush Pregnancy Test (3 HCG Midstreams) is intended for the qualitative determination of human chorionic gonadotropin (hCG) in the urine to aid in early detection of pregnancy. There are 3 6mm midstreams in one box. | Early Blush Pregnancy Test (3 HCG Midstreams) | RUNBIO BIOTECH CO., LTD. | |
45 | 06938444982184 | 82184 | Early Blush Pregnancy Test (30 HCG Strips) is intended for the qualitative dete Early Blush Pregnancy Test (30 HCG Strips) is intended for the qualitative determination of human chorionic gonadotropin (hCG) in the urine to aid in early detection of pregnancy. There are 30 strips in one box. | Early Blush Pregnancy Test (30 HCG Strips) | RUNBIO BIOTECH CO., LTD. | |
46 | 06938444981316 | 81316 | HCG Pregnancy Test Strip is a self-testing immunoassay designed for the qualitat HCG Pregnancy Test Strip is a self-testing immunoassay designed for the qualitative determination of human chorionic gonadotropin (hCG) in the urine to aid in early detection of pregnancy. It is for over-the-counter use. It consists of 25 strips. | INVBIO | RUNBIO BIOTECH CO., LTD. | |
47 | 06938444980012 | 80012 | RH-HCG-B | David Pregnancy Test is a self-testing immunoassay designed for the qualitative David Pregnancy Test is a self-testing immunoassay designed for the qualitative determination of human chorionic gonadotropin (hCG) in the urine to aid in early detection of pregnancy. It is for over-the-counter use. | DAVID PREGNANCY TEST MIDSTREAM | RUNBIO BIOTECH CO., LTD. |
48 | 06937579912134 | HCG-U24H | PARAID | NANTONG EGENS BIOLOGY TECHNIC CO., LTD. | ||
49 | 06937579911618 | HCG-M01 | Sure-Aid | NANTONG EGENS BIOLOGY TECHNIC CO., LTD. | ||
50 | 06937579911601 | HCG-C01 | Sure-Aid | NANTONG EGENS BIOLOGY TECHNIC CO., LTD. |