No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00850003500560 | OT30 | 791.77 | Bluetooth Basal Thermometer with Ovy App | LHD | Device, Fertility Diagnostic, Proceptive | U | OVY by Beurer |
2 | 00850003500843 | EM59 | TENS Device | NUH | Stimulator, Nerve, Transcutaneous, Over-The-Counter | 2 | Beurer | |
3 | 00853879007997 | CM100 | Art.-No. 590.70 | Massager | ISA | Massager, Therapeutic, Electric | 1 | Beurer |
4 | 00853879007935 | HT15 | Art.- No. 591.71 | Lice Comb (Powered) | LJL | Detectors And Removers, Lice, (Including Combs) | 1 | Beurer |
5 | 00853879007751 | BF195 | Art. No. 747.93 | Body Fat Scale | PUH | Analyzer, Body Composition, Exempt | 2 | Beurer |
6 | 00853879007508 | BF130 (silver) | Art.- No 735.71 (silver) | Body Fat Scale | PUH | Analyzer, Body Composition, Exempt | 2 | Beurer |
7 | 00853879007331 | EM34 | Tens Device Knee / Elbow 2 in 1For the temporary relief of pain associated with Tens Device Knee / Elbow 2 in 1For the temporary relief of pain associated with sore and aching muscles | NUH | Stimulator, Nerve, Transcutaneous, Over-The-Counter | 2 | Beurer | |
8 | 00853879007324 | BY70 | Art.- No. 953.70 | Electric dual breast pump | HGX | Pump, Breast, Powered | 2 | Beurer |
9 | 00853879007300 | EM44 Replacement Electrodes Set | Art.- No. 642.72 | Replacement Electrodes Set for use with EM44 Beurer TENS Device (Art.- No. 642.71) | GXY | Electrode, Cutaneous | Beurer | |
10 | 00853879007287 | EM44 | Digital TENS Device | NUH | Stimulator, Nerve, Transcutaneous, Over-The-Counter | 2 | Beurer | |
11 | 00853879007140 | EM37 | Art.- No. 642.77 | EMS Abdominal Muscle Belt | NGX | Stimulator, Muscle, Powered, For Muscle Conditioning | 2 | Beurer |
12 | 00853879007119 | PO60 (Art.-No.454.73) | Bluetooth® Pulse Oximeter for wellnessuse | PGJ | Oximeter, Wellness | 2 | Beurer | |
13 | 00853879007072 | BC57 (Art.-No. 656.74) | Type KD-721 | Wrist Bluetooth® Blood Pressure Monitor | DXN | System, Measurement, Blood-Pressure, Non-Invasive | 2 | Beurer |
14 | 00853879007065 | BF70 (Art.-No. 747.70) | BF70 Bluetooth® Diagnostic Scale | PUH | Analyzer, Body Composition, Exempt | 2 | Beurer | |
15 | 00853879007058 | BM67 | Art.- No 659.69 | BM67 Bluetooth® Upper Arm Blood Pressure Monitor* with standard cuff 8.7 - 14.2 BM67 Bluetooth® Upper Arm Blood Pressure Monitor* with standard cuff 8.7 - 14.2 in (22 - 36 cm)* with universal cuff size 8.7 - 17.3 in (22 - 44 cm) | DXN | System, Measurement, Blood-Pressure, Non-Invasive | 2 | Beurer |
16 | 00853879007027 | HA50 (Art.- No. 641.71) | Wearable air-conduction hearing aid - wearable sound-amplifying device that is i Wearable air-conduction hearing aid - wearable sound-amplifying device that is intended to compensate for impaired hearing. | ESD | Hearing Aid, Air Conduction | Beurer | ||
17 | 00852547004924 | BF525 | Glass Body Analysis Scale | PUH | Analyzer, Body Composition, Exempt | 2 | Beurer | |
18 | 00852547004832 | MG800 | Art.-No. 640.70 | Fascia Massager | ISA | Massager, Therapeutic, Electric | 1 | Beurer |
19 | 00852547004733 | IPL7500 (Art.-No. 575.71) | Light based, over the counter device intended for the removal of unwanted hair a Light based, over the counter device intended for the removal of unwanted hair as well as permanent reduction in hair regrowth. | OHT | Light Based Over-The-Counter Hair Removal | 2 | Beurer | |
20 | 00852547004719 | FT58 IR Ear Thermometer | Art.- No. 795.79 | IR Ear Thermometer | FLL | Thermometer, Electronic, Clinical | 2 | Beurer |
21 | 00852547004702 | BM26 | 652.72 | Upper Arm Blood Pressure Monitor | DXN | System, Measurement, Blood-Pressure, Non-Invasive | 2 | Beurer |
22 | 00852547004696 | BC30 (Art.-No.650.70) | Type BC30/1 | Wrist Blood Pressure Monitor | DXN | System, Measurement, Blood-Pressure, Non-Invasive | 2 | Beurer |
23 | 00852547004641 | BC81 | Type BC80 | Wrist Blood Pressure Monitor | DXN | System, Measurement, Blood-Pressure, Non-Invasive | 2 | Beurer |
24 | 00852547004603 | BM47 Universal Cuff (replacement) | BM47 Universal Cuff (replacement) | DXN | System, Measurement, Blood-Pressure, Non-Invasive | Beurer | ||
25 | 00852547004559 | BF350 | Glass Body Analysis Scale | PUH | Analyzer, Body Composition, Exempt | 2 | Beurer | |
26 | 00852547004450 | BM47 XL Cuff (replacement) (Item No. 163.859) | BM47 XL Cuff (replacement) | DXN | System, Measurement, Blood-Pressure, Non-Invasive | 2 | Beurer | |
27 | 00852547004399 | BF130 | Art.- No 735.70 (grey) | Body Fat Scale | PUH | Analyzer, Body Composition, Exempt | 2 | Beurer |
28 | 00852547004344 | EM38 | TENS Device | NUH | Stimulator, Nerve, Transcutaneous, Over-The-Counter | 2 | Beurer | |
29 | 00852547004283 | BM55 | Art.- No 658.78 | Upper Arm Blood Pressure Monitor* with cuff size 8.7 - 16.5 in (22 - 42 cm) | DXN | System, Measurement, Blood-Pressure, Non-Invasive | 2 | Beurer |
30 | 00852547004276 | BM47 Blood Pressure Monitor with Universal Cuff | 660.73 | BM47 Blood Pressure Monitor with Universal Cuff (22 - 42 cm) | DXN | System, Measurement, Blood-Pressure, Non-Invasive | 2 | Beurer |
31 | 00852547004269 | BF221 (Art.-No. 740.79) | Type BF220 | Body Fat Scale | PUH | Analyzer, Body Composition, Exempt | 2 | Beurer |
32 | 00852547004214 | PO30 | Art.- No. 454.71 | Fingertip Pulse Oximeter (for wellness) | PGJ | Oximeter, Wellness | 2 | Beurer |
33 | 00852547004184 | BF520 | 760.71 | Glass Body Analysis Scale | MNW | Analyzer, Body Composition | 2 | Beurer |
34 | 00852547004122 | FT90 | Type FT90/1 | Non-contact IR Clinical Thermometer | FLL | Thermometer, Electronic, Clinical | 2 | Beurer |
35 | 00852547004115 | BF220 | Body Fat Scale | PUH | Analyzer, Body Composition, Exempt | 2 | Beurer | |
36 | 00852547004108 | IL50 | Infrared Lamp | ILY | Lamp, Infrared, Therapeutic Heating | 2 | Beurer | |
37 | 00852547004054 | IH50 | Portable Nebulizer | CAF | Nebulizer (Direct Patient Interface) | 2 | Beurer | |
38 | 00852547004009 | FT58 Disposable Probe Covers | IR EAR THERMOMETER DISPOSABLE PROBE COVERS | FLL | Thermometer, Electronic, Clinical | Beurer | ||
39 | 00850018808729 | EM50RP | 664.98 | EM50 RP,TENS Therapy Replacement Gel Pads, 6 Gel Pads | GXY | Electrode, Cutaneous | Beurer | |
40 | 00850018808699 | CEM50 | 661.32 | Menstrual RelaxCombines TENS + Heat that helps ease menstrual symptoms | NUH | Stimulator, Nerve, Transcutaneous, Over-The-Counter | Beurer | |
41 | 00850018808316 | BM81 | 655.71 | easyLock Upper Arm Blood Pressure Monitor | DXN | System, Measurement, Blood-Pressure, Non-Invasive | 2 | Beurer |
42 | 00850018808224 | BR60 | 607.58 | Insect Bite Healer | IRT | Pad, Heating, Powered | 2 | Beurer |
43 | 00850018808217 | SI30 | 603.82 | Steam Inhaler | KFZ | Humidifier, Non-Direct Patient Interface (Home-Use) | 1 | Beurer |
44 | 00850018808170 | FT13 | 791.48 | Digital Thermometer | FLL | Thermometer, Electronic, Clinical | 2 | Beurer |
45 | 00850018808163 | CEM44 | 642.75 | Digital TENS Device | NUH | Stimulator, Nerve, Transcutaneous, Over-The-Counter | 2 | Beurer |
46 | 00850018808156 | EM50 | 650.76 | Menstrual RelaxCombines TENS + Heat that helps ease menstrual symptoms | NUH | Stimulator, Nerve, Transcutaneous, Over-The-Counter | Beurer | |
47 | 00850018808095 | FT65 | 795.33 | Infrared Thermometer | FLL | Thermometer, Electronic, Clinical | 2 | Beurer |
48 | 00850018808071 | FT65 | 796.32 | Infrared Thermometer | FLL | Thermometer, Electronic, Clinical | 2 | Beurer |
49 | 00850018808019 | BM31 | 656.69 | UPPER ARM BLOOD PRESSURE MONITOR (with cuff 22-42 cm). | DXN | System, Measurement, Blood-Pressure, Non-Invasive | Beurer | |
50 | 00850018808002 | PO50 | 453.76 | Pulse Oximeter for use with sporting and aviation activities. Intended to monito Pulse Oximeter for use with sporting and aviation activities. Intended to monitor heart rate during exercise. | OCH | Oximeter, Infrared, Sporting, Aviation | 2 | Beurer |
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 | 09120095900021 | 1 | femSense Fertility | STEADYSENSE GMBH | ||
5 | 09120095900014 | 1 | femSense Kinderwunsch | STEADYSENSE GMBH | ||
6 | 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 | |
7 | 08809408860245 | SU-DR01-LH | HLHM020E | Surearly™ Digital OvulationTest in an in vitro diagnostic medical devices for th Surearly™ Digital OvulationTest in an in vitro diagnostic medical devices for the rapid determination of Luteinizing Hormone (LH) in urine. The test is for the qualitative detection of LH to predict a woman’s most fertile period. It is intended for non-professional, over-the-counter (OTC) use only. | Surearly™ Digital Ovulation Test | SUGENTECH INC._OSONG BRANCH |
8 | 08809408860214 | SU-DR01-LH | HLHM007E | Surearly™ Digital OvulationTest in an in vitro diagnostic medical devices for th Surearly™ Digital OvulationTest in an in vitro diagnostic medical devices for the rapid determination of Luteinizing Hormone (LH) in urine. The test is for the qualitative detection of LH to predict a woman’s most fertile period. It is intended for non-professional, over-the-counter (OTC) use only. | Surearly™ Digital Ovulation Test | SUGENTECH INC._OSONG BRANCH |
9 | 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 |
10 | 08719699634633 | FK-127-CO | FK-127A contains 50 ovulation test and 20 pregnancy tests. | iProven | SEVENGROUND TRADING B.V. | |
11 | 08719699633254 | FMH-139-3 | FMH-139 is a One Step HCG Urine Pregnancy Test | iProven | SEVENGROUND TRADING B.V. | |
12 | 08719699633230 | FMH-139-5 | FMH-139 is a One Step HCG Urine Pregnancy Test | iProven | SEVENGROUND TRADING B.V. | |
13 | 08719699630901 | FMH-139-5 | FMH-139 is a One Step HCG Urine Pregnancy Test | iProven | SEVENGROUND TRADING B.V. | |
14 | 08719481722043 | FMH-139-5 | Box with five midstream pregnancy tests | iProvèn | MASENA INVEST B.V. | |
15 | 08719481722029 | FMH-139-3 | Box with three midstream pregnancy tests | iProvèn | MASENA INVEST B.V. | |
16 | 08719481721077 | FK-127s-A | Fertility KIT with 30 teststrips | iProvèn | MASENA INVEST B.V. | |
17 | 08719481721077 | FK-127s-A | Fertility KIT with 30 teststrips | iProvèn | MASENA INVEST B.V. | |
18 | 08719481721060 | FL-50-LH-A | Box with 35 ovulation teststrips | iProvèn | MASENA INVEST B.V. | |
19 | 08719481721053 | FL-50-A | Box with 50 ovulation teststrips | iProvèn | MASENA INVEST B.V. | |
20 | 08719481721046 | FH-30-HCG-A | Box with 30 pregnancy teststrips | iProvèn | MASENA INVEST B.V. | |
21 | 08719481720865 | FK-127-A | Fertility KIT with 70 teststrips | iProvèn | MASENA INVEST B.V. | |
22 | 08719481720865 | FK-127-A | Fertility KIT with 70 teststrips | iProvèn | MASENA INVEST B.V. | |
23 | 08719481720773 | FL-35 | Box with 35 ovulation teststrips | iProvèn | MASENA INVEST B.V. | |
24 | 08719481720766 | FL-50 | Box with 50 ovulation teststrips | iProvèn | MASENA INVEST B.V. | |
25 | 08719481720759 | FH-30 | Box with 30 pregnancy teststrips | iProvèn | MASENA INVEST B.V. | |
26 | 08719481720728 | FK-127s | Box with 25 ovulation teststrips and 5 pregnancy teststrips | iProvèn | MASENA INVEST B.V. | |
27 | 08719481720179 | FK-127-W-HCGtest | HCG strips - pregnancy test strips - REGISTRATION NUMBER HCG STRIP: 21 CFR 862.1155 | iProvèn | MASENA INVEST B.V. | |
28 | 08719481720162 | FK-127-HCGtest | HCG strips - pregnancy test strips | iProvèn | MASENA INVEST B.V. | |
29 | 07640184680464 | 2.1 | PNA00046 | Ava Fertility is intended to measure and display physiological parameters (body Ava Fertility is intended to measure and display physiological parameters (body temperature, resting pulse rate, heart rate variability, and breathing rate) as an aid in ovulation prediction to facilitate conception (not to be used for contraception). It is a non-invasive device made up of a sensor bracelet, a mobile application and a backend system including the trying to conceive (TTC) algorithm. | Ava Fertility | AVA SCIENCES-FMTC GMBH |
30 | 07640184680136 | 2.0 | PNA00013 | Ava Fertility is intended to measure and display physiological parameters (body Ava Fertility is intended to measure and display physiological parameters (body temperature, resting pulse rate, heart rate variability, and breathing rate) as an aid in ovulation prediction to facilitate conception (not to be used for contraception). It is a non-invasive device made up of a sensor bracelet, a mobile application and a backend system including the trying to conceive (TTC) algorithm. | Ava Fertility | AVA SCIENCES-FMTC GMBH |
31 | 07350014630285 | 0001 | Clearblue by NC | NATURALCYCLES NORDIC AB | ||
32 | 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 | |
33 | 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 | |
34 | 07350014630155 | 15 | Test, Pregnancy, Hcg, Over The Counter | Natural Cycles | NATURALCYCLES NORDIC AB | |
35 | 07350014630148 | 14 | Test, Luteinizing Hormone (Lh), Over The Counter | Natural Cycles | NATURALCYCLES NORDIC AB | |
36 | 07290016672213 | TytoHome | 900-00015 | TytoHome used for comprehensive remote exam and telehealth.TytoCare device with TytoHome used for comprehensive remote exam and telehealth.TytoCare device with high resolution video and still camera, no-touch infrared basal thermometer, stethoscope, otoscope and tongue depressor attachments.this is a convenience kit containing the following DIs: 07290016672183 Tyto Device with Basal Thermometer and Exam Camera, 07290016672190 Tyto Stethoscope and 07290016672206 Tyto Otoscope.TytoHome kits are shipped to the US in a logistic carton labeled with 17290016672210. | TytoHome | TYTO CARE LTD |
37 | 07290016672183 | Tyto Device | 800-00007 | The Tyto Device unit contains the Tyto Exam Camera and Tyto Basal Thermometer. I The Tyto Device unit contains the Tyto Exam Camera and Tyto Basal Thermometer. It is used also as the display (UI) and operation component of other TytoPro kit components: the Tyto Stethoscope and Tyto OttoscopeIntended use for Tyto Exam Camera:The Tyto Camera is an electronic camera that enables capturing and transmission of videoand still images of throat (w / w/o tongue depressor) and skin, whereby a clinician at onelocation on an IP network can view images and videos of a patient on site or at a differentlocation on the IP network with the signal carried on an IP connection between the twolocations.Intended use for Tyto Basal Thermometer:The Tyto Basal Thermometer is an electronic thermometer that enables measuring basalbody temperature as an aid in ovulation prediction to aid in conception (not to be usedfor contraception). In addition, the thermometer enables storage and transmitting thetemperature measurement to a clinician on site or at a different location on the IP networkwith the signal carried on an IP connection between the two locations. | Tyto Device | TYTO CARE LTD |
38 | 07290016672053 | TytoHome | 900-00015 | TytoHome used for comprehensive remote exam and telehealth.TytoCare device with TytoHome used for comprehensive remote exam and telehealth.TytoCare device with high resolution video and still camera, no-touch infrared basal thermometer, stethoscope, otoscope and tongue depressor attachments.this is a convenience kit containing the following DIs: 07290016672008 TytoCare, 07290016672015 Tyto Stethoscope and 07290016672022 Tyto Otoscope.TytoHome kits are shipped to the US in a logistic carton labeled with DI 17290016672050. | TytoHome | TYTO CARE LTD |
39 | 07290016672039 | TytoPro | 900-00002 | Designed for professional use, TytoPro used for comprehensive remote exam and te Designed for professional use, TytoPro used for comprehensive remote exam and telehealth.TytoCare device with high resolution video and still camera, no-touch infrared basal thermometer, stethoscope, otoscope and tongue depressor attachments.this is a convenience kit containing the following DIs: 07290016672008 TytoCare, 07290016672015 Tyto Stethoscope and 07290016672022 Tyto Otoscope.TytoPro kits are shipped to the US in a logistic carton labeled with DI 17290016672036. | TytoPro | TYTO CARE LTD |
40 | 07290016672008 | TytoCare | 800-00003 | The TytoCare unit contains the Tyto Exam Camera and Tyto Basal Thermometer. It i The TytoCare unit contains the Tyto Exam Camera and Tyto Basal Thermometer. It is used also as the display (UI) and operation component of other TytoPro kit components: the Tyto Stethoscope and Tyto OttoscopeIntended use for Tyto Exam Camera:The Tyto Camera is an electronic camera that enables capturing and transmission of videoand still images of throat (w / w/o tongue depressor) and skin, whereby a clinician at onelocation on an IP network can view images and videos of a patient on site or at a differentlocation on the IP network with the signal carried on an IP connection between the twolocations.Intended use for Tyto Basal Thermometer:The Tyto Basal Thermometer is an electronic thermometer that enables measuring basalbody temperature as an aid in ovulation prediction to aid in conception (not to be usedfor contraception). In addition, the thermometer enables storage and transmitting thetemperature measurement to a clinician on site or at a different location on the IP networkwith the signal carried on an IP connection between the two locations. | TytoCare | TYTO CARE LTD |
41 | 06974464590084 | 0741M4X003 | One Step HCG Urine Test Midstream | MissLan | GUANGZHOU DECHENG BIOTECHNOLOGY CO., LTD | |
42 | 06974464590077 | 0891D9G040 | Digital ovulation test (40 pieces per kit) | MissLan | GUANGZHOU DECHENG BIOTECHNOLOGY CO., LTD | |
43 | 06974464590060 | 0891D9G020 | Digital Ovulation Test (25mIU/ml), 20 pieces per kit | MissLan | GUANGZHOU DECHENG BIOTECHNOLOGY CO., LTD | |
44 | 06974464590053 | 0741M4X002 | LH and HCG combo test midstream | MissLan | GUANGZHOU DECHENG BIOTECHNOLOGY CO., LTD | |
45 | 06974464590053 | 0741M4X002 | LH and HCG combo test midstream | MissLan | GUANGZHOU DECHENG BIOTECHNOLOGY CO., LTD | |
46 | 06974464590046 | 0741M4X005 | LH and HCG combo test midstream | MissLan | GUANGZHOU DECHENG BIOTECHNOLOGY CO., LTD | |
47 | 06974464590046 | 0741M4X005 | LH and HCG combo test midstream | MissLan | GUANGZHOU DECHENG BIOTECHNOLOGY CO., LTD | |
48 | 06974464590039 | 0731S3X020 | LH and HCG combo test strip | MissLan | GUANGZHOU DECHENG BIOTECHNOLOGY CO., LTD | |
49 | 06974464590039 | 0731S3X020 | LH and HCG combo test strip | MissLan | GUANGZHOU DECHENG BIOTECHNOLOGY CO., LTD | |
50 | 06974464590022 | 0711S3X0100 | LH test strip, 100T | MissLan | GUANGZHOU DECHENG BIOTECHNOLOGY CO., LTD |