No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00850003500843 | EM59 | TENS Device | NUH | Stimulator, Nerve, Transcutaneous, Over-The-Counter | 2 | Beurer | |
2 | 00853879007997 | CM100 | Art.-No. 590.70 | Massager | ISA | Massager, Therapeutic, Electric | 1 | Beurer |
3 | 00853879007935 | HT15 | Art.- No. 591.71 | Lice Comb (Powered) | LJL | Detectors And Removers, Lice, (Including Combs) | 1 | Beurer |
4 | 00853879007751 | BF195 | Art. No. 747.93 | Body Fat Scale | PUH | Analyzer, Body Composition, Exempt | 2 | Beurer |
5 | 00853879007508 | BF130 (silver) | Art.- No 735.71 (silver) | Body Fat Scale | PUH | Analyzer, Body Composition, Exempt | 2 | Beurer |
6 | 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 | |
7 | 00853879007324 | BY70 | Art.- No. 953.70 | Electric dual breast pump | HGX | Pump, Breast, Powered | 2 | Beurer |
8 | 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 | |
9 | 00853879007287 | EM44 | Digital TENS Device | NUH | Stimulator, Nerve, Transcutaneous, Over-The-Counter | 2 | Beurer | |
10 | 00853879007140 | EM37 | Art.- No. 642.77 | EMS Abdominal Muscle Belt | NGX | Stimulator, Muscle, Powered, For Muscle Conditioning | 2 | Beurer |
11 | 00853879007119 | PO60 (Art.-No.454.73) | Bluetooth® Pulse Oximeter for wellnessuse | PGJ | Oximeter, Wellness | 2 | Beurer | |
12 | 00853879007072 | BC57 (Art.-No. 656.74) | Type KD-721 | Wrist Bluetooth® Blood Pressure Monitor | DXN | System, Measurement, Blood-Pressure, Non-Invasive | 2 | Beurer |
13 | 00853879007065 | BF70 (Art.-No. 747.70) | BF70 Bluetooth® Diagnostic Scale | PUH | Analyzer, Body Composition, Exempt | 2 | Beurer | |
14 | 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 |
15 | 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 | ||
16 | 00852547004924 | BF525 | Glass Body Analysis Scale | PUH | Analyzer, Body Composition, Exempt | 2 | Beurer | |
17 | 00852547004832 | MG800 | Art.-No. 640.70 | Fascia Massager | ISA | Massager, Therapeutic, Electric | 1 | Beurer |
18 | 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 | |
19 | 00852547004719 | FT58 IR Ear Thermometer | Art.- No. 795.79 | IR Ear Thermometer | FLL | Thermometer, Electronic, Clinical | 2 | Beurer |
20 | 00852547004702 | BM26 | 652.72 | Upper Arm Blood Pressure Monitor | DXN | System, Measurement, Blood-Pressure, Non-Invasive | 2 | Beurer |
21 | 00852547004696 | BC30 (Art.-No.650.70) | Type BC30/1 | Wrist Blood Pressure Monitor | DXN | System, Measurement, Blood-Pressure, Non-Invasive | 2 | Beurer |
22 | 00852547004641 | BC81 | Type BC80 | Wrist Blood Pressure Monitor | DXN | System, Measurement, Blood-Pressure, Non-Invasive | 2 | Beurer |
23 | 00852547004603 | BM47 Universal Cuff (replacement) | BM47 Universal Cuff (replacement) | DXN | System, Measurement, Blood-Pressure, Non-Invasive | Beurer | ||
24 | 00852547004559 | BF350 | Glass Body Analysis Scale | PUH | Analyzer, Body Composition, Exempt | 2 | Beurer | |
25 | 00852547004450 | BM47 XL Cuff (replacement) (Item No. 163.859) | BM47 XL Cuff (replacement) | DXN | System, Measurement, Blood-Pressure, Non-Invasive | 2 | Beurer | |
26 | 00852547004399 | BF130 | Art.- No 735.70 (grey) | Body Fat Scale | PUH | Analyzer, Body Composition, Exempt | 2 | Beurer |
27 | 00852547004344 | EM38 | TENS Device | NUH | Stimulator, Nerve, Transcutaneous, Over-The-Counter | 2 | Beurer | |
28 | 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 |
29 | 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 |
30 | 00852547004269 | BF221 (Art.-No. 740.79) | Type BF220 | Body Fat Scale | PUH | Analyzer, Body Composition, Exempt | 2 | Beurer |
31 | 00852547004214 | PO30 | Art.- No. 454.71 | Fingertip Pulse Oximeter (for wellness) | PGJ | Oximeter, Wellness | 2 | Beurer |
32 | 00852547004184 | BF520 | 760.71 | Glass Body Analysis Scale | MNW | Analyzer, Body Composition | 2 | Beurer |
33 | 00852547004122 | FT90 | Type FT90/1 | Non-contact IR Clinical Thermometer | FLL | Thermometer, Electronic, Clinical | 2 | Beurer |
34 | 00852547004115 | BF220 | Body Fat Scale | PUH | Analyzer, Body Composition, Exempt | 2 | Beurer | |
35 | 00852547004108 | IL50 | Infrared Lamp | ILY | Lamp, Infrared, Therapeutic Heating | 2 | Beurer | |
36 | 00852547004054 | IH50 | Portable Nebulizer | CAF | Nebulizer (Direct Patient Interface) | 2 | Beurer | |
37 | 00852547004009 | FT58 Disposable Probe Covers | IR EAR THERMOMETER DISPOSABLE PROBE COVERS | FLL | Thermometer, Electronic, Clinical | Beurer | ||
38 | 00850018808729 | EM50RP | 664.98 | EM50 RP,TENS Therapy Replacement Gel Pads, 6 Gel Pads | GXY | Electrode, Cutaneous | Beurer | |
39 | 00850018808699 | CEM50 | 661.32 | Menstrual RelaxCombines TENS + Heat that helps ease menstrual symptoms | NUH | Stimulator, Nerve, Transcutaneous, Over-The-Counter | Beurer | |
40 | 00850018808316 | BM81 | 655.71 | easyLock Upper Arm Blood Pressure Monitor | DXN | System, Measurement, Blood-Pressure, Non-Invasive | 2 | Beurer |
41 | 00850018808224 | BR60 | 607.58 | Insect Bite Healer | IRT | Pad, Heating, Powered | 2 | Beurer |
42 | 00850018808217 | SI30 | 603.82 | Steam Inhaler | KFZ | Humidifier, Non-Direct Patient Interface (Home-Use) | 1 | Beurer |
43 | 00850018808170 | FT13 | 791.48 | Digital Thermometer | FLL | Thermometer, Electronic, Clinical | 2 | Beurer |
44 | 00850018808163 | CEM44 | 642.75 | Digital TENS Device | NUH | Stimulator, Nerve, Transcutaneous, Over-The-Counter | 2 | Beurer |
45 | 00850018808156 | EM50 | 650.76 | Menstrual RelaxCombines TENS + Heat that helps ease menstrual symptoms | NUH | Stimulator, Nerve, Transcutaneous, Over-The-Counter | Beurer | |
46 | 00850018808095 | FT65 | 795.33 | Infrared Thermometer | FLL | Thermometer, Electronic, Clinical | 2 | Beurer |
47 | 00850018808071 | FT65 | 796.32 | Infrared Thermometer | FLL | Thermometer, Electronic, Clinical | 2 | Beurer |
48 | 00850018808019 | BM31 | 656.69 | UPPER ARM BLOOD PRESSURE MONITOR (with cuff 22-42 cm). | DXN | System, Measurement, Blood-Pressure, Non-Invasive | Beurer | |
49 | 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 |
50 | 00850003500881 | EM59RP Replacement Electrodes | Replacement Electrodes for EM59 TENS/Heat Device | GXY | Electrode, Cutaneous | 2 | Beurer |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 00850003500560 | OT30 | 791.77 | Bluetooth Basal Thermometer with Ovy App | OVY by Beurer | BEURER NORTH AMERICA, L.P. |
2 | 00850003500478 | OT80 | 792.97 | Beurer Fertility Convenience Kit with Pearl AppEach kit contains:15 FSH test str Beurer Fertility Convenience Kit with Pearl AppEach kit contains:15 FSH test strips,15 LH test strips,2 hCG test strips (pregnancy test),Access (activation code) for the Pearl Fertility App. | Beurer | BEURER NORTH AMERICA, L.P. |
3 | 00850003500430 | OT20 | 790.70 | Ovy by Beurer Basal Thermometer with Ovy App | Beurer | BEURER NORTH AMERICA, L.P. |
4 | 00194252845974 | Feature Version 3.x | Cycle Tracking iPhone App (Version 3.0) | Cycle Tracking 3.0 | APPLE INC. | |
5 | 00194252845967 | Feature Version 3.x | Cycle Tracking Watch App (Version 3.0) | Cycle Tracking 3.0 | APPLE INC. | |
6 | 09120095900021 | 1 | femSense Fertility | STEADYSENSE GMBH | ||
7 | 09120095900014 | 1 | femSense Kinderwunsch | STEADYSENSE GMBH | ||
8 | 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 |
9 | 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 |
10 | 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 |
11 | 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 |
12 | 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 |
13 | 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 |
14 | 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 |
15 | 06957324200125 | WT702 | raiing iFertracker | RAIING MEDICAL COMPANY | ||
16 | 06938444982498 | 82498 | OT80-Beurer Ovulation Predictor and Fertility Tracking Kit | RUNBIO BIOTECH CO., LTD. | ||
17 | 05060508530121 | M400 | M400 OvuFirst Starter Pack - M426 OvuFirst Skin Worn Sensor and M032 OvuSense App | OvuSense | FERTILITY FOCUS LIMITED | |
18 | 05060508530114 | M032 Android | OvuSense 2 App - Android | OvuSense | FERTILITY FOCUS LIMITED | |
19 | 05060508530107 | M032 iOS | OvuSense 2 App - iOS | OvuSense | FERTILITY FOCUS LIMITED | |
20 | 05060508530091 | M426 | M426 OvuFirst Skin Worn Sensor | OvuSense | FERTILITY FOCUS LIMITED | |
21 | 05060508530053 | M026 | M026 OvuCore Vaginal Sensor | OvuSense | FERTILITY FOCUS LIMITED | |
22 | 05060508530039 | M300 | M300 OvuCore Starter Pack - M026 OvuCore Vaginal Sensor and M032 OvuSense App | OvuSense | FERTILITY FOCUS LIMITED | |
23 | 04715309129425 | U-TW1 | Mini Ovulation Microscope for Smartphone is to observe the density of fern cryst Mini Ovulation Microscope for Smartphone is to observe the density of fern crystallization from your saliva(NaCI) to determine whether or not has ovulated. | NA | PANPAC MEDICAL CORPORATION |