| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 04719878122023 | GSH202-B | The Body Fat Analyzer measures weight and estimate BMI and calories, and uses bi The Body Fat Analyzer measures weight and estimate BMI and calories, and uses bio-electrical impedance analysis (BIA) technology to estimate body fat ratio, water ratio, bone mineral mass, visceral fat level, protein and muscle mass in health adults. It is intended for use in the domestic setting only.Contraindications:1. The device is contraindicated for any female subject who may be suspected of, or is pregnant. Besides provided inaccurate readings, the affects of this device on the fetus are unknown. 2. The device is contraindicated for any person who is connected to a wearable or implantable electronic device or instrument such as a pacemaker or defibrillator. | PUH | Analyzer, Body Composition, Exempt | 2 | WowGoHealth Body Fat Analyzer GSH202-B | |
| 2 | 04719878120029 | GSH885B | The WowGoHealth Blood Pressure Monitor GSH885B is digital monitors intended for The WowGoHealth Blood Pressure Monitor GSH885B is digital monitors intended for use in measuring blood pressure and heartbeat rate with arm circumference rangingfrom 22 cm to 32 cm or 22cm to 42cm.It is intended for adult indoor use only.Contraindications:1. The device is not suitable for use on may be pregnant women or pregnant women.2. The device is not suitable for use on patients with implanted,electrical devices, such as cardiac pacemakers, defibrillators. | DXN | System, Measurement, Blood-Pressure, Non-Invasive | 2 | WowGoHealth Blood Pressure Monitor GSH885B | |
| 3 | 04719878120012 | Blood Pressure Monitor LS802-B | The Blood Pressure Monitor LS802-B is digital monitor intended for use in measur The Blood Pressure Monitor LS802-B is digital monitor intended for use in measuring blood pressure and heartbeat rate in adult patient population with arm circumference ranging from 22 cm to 42 cm (about 9 - 17 inches). This device detects the appearance of irregular heartbeats during measurement and give a warning signal with readings.The LS802-B is not intended to be a diagnostic device. Contact your physician if hypertensive values are indicated.LS802-B embed a Bluetooth module that allows it to connect with nearby BT receiving terminal. | DXN | System, Measurement, Blood-Pressure, Non-Invasive | 2 | WowGoHealth | |
| 4 | 04719878124027 | GSH601 | Orange | The pulse oximeter is a reusable device, and it’s intended for intermittent chec The pulse oximeter is a reusable device, and it’s intended for intermittent checks of oxygen saturation and pulse rate for adults in a home-use only. This device is not intended for continuous monitoring. The device is intended to use of Over-The-Counter. | OCH | Oximeter, Infrared, Sporting, Aviation | WowGoHealth Pulse Oximeter GSH601 | |
| 5 | 04719878124010 | GSH601 | Gray | The pulse oximeter is a reusable device, and it’s intended for intermittent chec The pulse oximeter is a reusable device, and it’s intended for intermittent checks of oxygen saturation and pulse rate for adults in a home-use only. This device is not intended for continuous monitoring. The device is intended to use of Over-The-Counter. | OCH | Oximeter, Infrared, Sporting, Aviation | WowGoHealth Pulse Oximeter GSH601 | |
| 6 | 04719878122313 | GSH231 (A3K) | The Body Fat Analyzer measures weight and estimate BMI and calories, and uses bi The Body Fat Analyzer measures weight and estimate BMI and calories, and uses bio-electrical impedance analysis (BIA) technology to estimate body fat ratio, water ratio, bone mineral mass, visceral fat level, protein and muscle mass in healthy adults. This product is for indoor use only. | PUH | Analyzer, Body Composition, Exempt | 2 | WowGoHealth Bluetooth Body Fat Analyzer | |
| 7 | 04719878121019 | GSH-BGM902 | The WowGoHealth Blood Glucose Monitoring System (Model GSH-BGM902) consists of t The WowGoHealth Blood Glucose Monitoring System (Model GSH-BGM902) consists of the WowGoHealth Blood Glucose Monitor and the WowGoHealth Blood Glucose Test Strip. The WowGoHealth Blood Glucose Monitoring System (Model GSH-BGM902) is intended to be used for the quantitative measurement of glucose in fresh capillarywhole blood drawn from the fingertips or forearm. The WowGoHealth Blood Glucose Monitoring System (Model GSHBGM902) is intended to be used by a single person and should not be shared.The WowGoHealth Blood Glucose Monitoring System (Model GSH-BGM902) is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid in monitoring the effectiveness of a diabetes control program.The WowGoHealth Blood Glucose Monitoring System (Model GSH-BGM902) should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady state times (when glucose is not changing rapidly). | NBW | System, Test, Blood Glucose, Over The Counter | WowGoHealth Blood Glucose Monitoring System GSH-BGM902 | ||
| 8 | 04719878120036 | GSH862 | Automatic Arm Bluetooth Blood Pressure Monitor GSH862, intended to measure the s Automatic Arm Bluetooth Blood Pressure Monitor GSH862, intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm.The devices’ features include irregular pulse rhythm detection during measurement, and will display a alert signal with the reading when irregular heartbeat is detected.The devices’ feature include Bluetooth function to transmit data to an external Bluetooth device withwireless communication.The devices are intended to use of Over-The-Counter. | DXN | System, Measurement, Blood-Pressure, Non-Invasive | 2 | WowGoHealth Automatic Arm Bluetooth Blood Pressure Monitor | |
| 9 | 04719878123013 | GSH-BTS301 | The WowGoHealth IR Ear Thermometer with Bluetooth (Model GSH-BTS301) is an infra The WowGoHealth IR Ear Thermometer with Bluetooth (Model GSH-BTS301) is an infrared thermometer intended for the intermittent measurement of human body temperature in people of all ages. | FLL | Thermometer, Electronic, Clinical | WowGoHealth IR Ear Thermometer with Bluetooth GSH-BTS301 | ||
| 10 | 04719878121156 | GSH-BGM902 - Level 1 | The WowGoHealth Control Solution should be tested on WowGoHealth meter using Wow The WowGoHealth Control Solution should be tested on WowGoHealth meter using WowGoHealth test strips to make sure the meter and test strips are working properly. | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | WowGoHealth Control Solution - GSH-BGM902 - Level 1 |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 05060141250493 | 200-25 | microdot xtra blood glucose test strip for use with microdot xtra meter | microdot xtra blood glucose test strip | CAMBRIDGE SENSORS LTD | |
| 2 | 05060141250189 | 200-50 | microdot xtra blood glucose test strip for use with microodt xtra meter | microdot xtra blood glucose test strip | CAMBRIDGE SENSORS LTD | |
| 3 | 05060141250035 | 100-50 | microdot Blood gucose test strips for use with micodot Blood glucose meter | microdot Blood Glucose Test Strips | CAMBRIDGE SENSORS LTD | |
| 4 | 04719878121125 | GSH-BGM902 - 2*25 | The WowGoHealth Blood Glucose Test Strip is for the measurement of glucose in wh The WowGoHealth Blood Glucose Test Strip is for the measurement of glucose in whole blood. It is for In-vitro diagnostic use only. And the WowGoHealth test strips can only be used with WowGoHealth meter that has the same reference number. | WowGoHealth Blood Glucose Test Strips - GSH-BGM902 - 2*25 | GOLDEN SMART HOME TECHNOLOGY CORP. | |
| 5 | 04719871820339 | 5819 | NuvoMed Glucose Test strip-25 pc | NuvoMed | BIOTEST MEDICAL CORPORATION | |
| 6 | 04719871820315 | P5228 BGM-6/0352 | NuvoMed Wireless Blood Glucose Monitoring System | NuvoMed | BIOTEST MEDICAL CORPORATION | |
| 7 | 04711200721850 | AC11-NFC | 3K-01-16003G | The GoodLife AC-300 Professional Blood Glucose Monitoring System.(No NFC) | GL GoodLife | HMD BIOMEDICAL INC. |
| 8 | 04711200721034 | 3L-10-160032 | 3L-10-160032 | GoodLife Blood Glucose ACH foil packed test strip. | GoodLife foil packed test strip | HMD BIOMEDICAL INC. |
| 9 | 04260236851326 | 3S-01-1400332 | 3S-01-1400332 | FIA Salut Blood Glucose KPH vial packed test strip(for SS) | FIA Salut vial packed test strip(for SS) | HMD BIOMEDICAL INC. |
| 10 | 04260236851159 | 3S-01-160037 | 3S-01-160037 | PRECICHEK AutoCode Blood Glucose ACH vial packed test strip. | PRECICHEK AutoCode vial packed test strip | HMD BIOMEDICAL INC. |
| 11 | 04260236851142 | 3L-10-16003B | 3L-10-16003B | PRECICHEK AutoCode Blood Glucose ACH foil packed test strip | PRECICHEK AutoCode foil packed test strip | HMD BIOMEDICAL INC. |
| 12 | 04260236851111 | 3L-10-16003H | 3L-10-16003H | PRECICHEK AutoCode Blood Glucose ACH foil packed test strip | PRECICHEK AutoCode foil packed test strip | HMD BIOMEDICAL INC. |
| 13 | 04260236851067 | 3L-10-16003G | 3L-10-16003G | PRECICHEK AutoCode Blood Glucose ACH foil packed test strip | PRECICHEK AutoCode foil packed test strip | HMD BIOMEDICAL INC. |
| 14 | 04260236851050 | 3K-01-16003X | 3K-01-16003X | PRECICHEK AC300 Blood Glucose Monitoring System. | PRECICHEK AC300 | HMD BIOMEDICAL INC. |
| 15 | 04260236851012 | 3S-01-1400A2 | 3S-01-1400A2 | FIA Salut Blood Glucose KPH vial packed test strip | FIA Salut vial packed test strip | HMD BIOMEDICAL INC. |
| 16 | 04260236851005 | 3S-01-1400A1 | 3S-01-1400A1 | FIA Salut Blood Glucose KPH vial packed test strip(for SS) | FIA Salut vial packed test strip(for SS) | HMD BIOMEDICAL INC. |
| 17 | 04260236850916 | 3S-01-16003F | 3S-01-16003F | PRECICHEK AutoCode Blood Glucose ACH vial packed test strip. | PRECICHEK AutoCode vial packed test strip | HMD BIOMEDICAL INC. |
| 18 | 04260236850848 | 3S-01-140996 | 3S-01-140996 | FIA Salut Blood Glucose KPH vial packed test strip(for Elhenawy) | FIA Salut vial packed test strip(for Elhenawy) | HMD BIOMEDICAL INC. |
| 19 | 04260236850664 | 3L-10-16003D | 3L-10-16003D | PRECICHEK AutoCode Blood Glucose ACH foil packed test strip | PRECICHEK AutoCode foil packed test strip | HMD BIOMEDICAL INC. |
| 20 | 04260236850619 | 3K-01-16003A | 3K-01-16003A | PRECICHEK AutoCode AC302 Blood Glucose Monitoring System. | PRECICHEK AutoCode AC302 | HMD BIOMEDICAL INC. |
| 21 | 04260236850480 | 3S-01-1400334 | 3S-01-1400334 | FIA Salut Blood Glucose KPH vial packed test strip | FIA Salut vial packed test strip | HMD BIOMEDICAL INC. |
| 22 | 04260236850466 | 3S-01-1400335 | 3S-01-1400335 | FIA Salut Blood Glucose KPH vial packed test strip. | FIA Salut vial packed test strip | HMD BIOMEDICAL INC. |
| 23 | 04260236850459 | 3L-10-14003A | 3L-10-14003A | FIA Salut Blood Glucose KPH foil packed test strip(for SS) | FIA Salut foil packed test strip(for SS) | HMD BIOMEDICAL INC. |
| 24 | 04260236850411 | 3S-01-160032 | 3S-01-160032 | PRECICHEK AutoCode Blood Glucose ACH vial packed test strip | PRECICHEK AutoCode vial packed test Strip | HMD BIOMEDICAL INC. |
| 25 | 04260236850367 | 3L-10-140033 | 3L-10-140033 | FIA Salut Blood Glucose KPH foil packed test strip | FIA Salut foil packed test strip | HMD BIOMEDICAL INC. |
| 26 | 04260236850329 | 3L-10-160031 | 3L-10-160031 | PRECICHEK AutoCode Blood Glucose ACH foil packed test strip | PRECICHEK AutoCode foil packed test strip | HMD BIOMEDICAL INC. |
| 27 | 04260236850244 | 3K-01-1400316 | 3K-01-1400316 | FIA Salut CS06 Blood Glucose Monitoring System. | FIA Salut CS06 | HMD BIOMEDICAL INC. |
| 28 | 00894030002970 | APX03AB0300PRE | Embrace TALK Blood Glucose Monitor (Pre-Pack) | OMNIS HEALTH, LLC | ||
| 29 | 00894030002963 | APX03AB0312HWPR | 3 x Embrace TALK Monitor12 x Embrace TALK Test Strip 50ct. | HealthWise Embrace TALK Pre-Pack (3x12) | OMNIS HEALTH, LLC | |
| 30 | 00894030002949 | APX03AB0303MO | Embrace TALK 50 ct. test strip (Mail Order) | OMNIS HEALTH, LLC | ||
| 31 | 00894030002918 | AXP03AB0319 | Embrace TALK 25 ct. test strip | OMNIS HEALTH, LLC | ||
| 32 | 00894030002833 | APX03AB0314HW | HealthWise Embrace TALK Blood Glucose Test Strips (50 ct.) | OMNIS HEALTH, LLC | ||
| 33 | 00894030002826 | APX03AB0313HW | HealthWise Embrace TALK Blood Glucose Monitoring System (Starter Kit) | OMNIS HEALTH, LLC | ||
| 34 | 00894030002727 | APX03AB0304 | Embrace TALK 100 ct. test strip | OMNIS HEALTH, LLC | ||
| 35 | 00894030002710 | APX03AB0303 | Embrace TALK 50 ct. test strip | OMNIS HEALTH, LLC | ||
| 36 | 00894030002703 | APX02AB0510 | Embrace Control Solution Low | OMNIS HEALTH | ||
| 37 | 00894030002697 | APX02AB0511 | Embrace Control Solution Hi | OMNIS HEALTH | ||
| 38 | 00894030002680 | APX02AB0502 | Embrace 50ct Test Strip | OMNIS HEALTH | ||
| 39 | 00894030002666 | APX01AB0500VK | Embrace Value Kit (50ct Included) | OMNIS HEALTH | ||
| 40 | 00894030002611 | APX01AB0200N | Embrace Blood Glucose Monitor | OMNIS HEALTH, LLC | ||
| 41 | 00894030002581 | APX02GS0202RF | Embrace Gestational Diabetes Package - RETAIL (5 vials) | OMNIS HEALTH | ||
| 42 | 00894030002574 | APX02GS0202RF | Embrace Gestational Diabetes - Strips Refill Bundle (4 vials) | OMNIS HEALTH | ||
| 43 | 00894030002567 | APX01GS0200-L | Embrace Gestational Diabetes Package - LARGE (9 vials) | OMNIS HEALTH | ||
| 44 | 00894030002550 | APX01GS0200-S | Embrace Gestational Diabetes Package - SMALL (5 vials) | OMNIS HEALTH | ||
| 45 | 00894030002543 | APX01AGS0100-SR | EmbraceEVO Gestational Diabetes Package - RETAIL (5 vials) | OMNIS HEALTH | ||
| 46 | 00894030002536 | APX01AK0200VK | Embrace Meter Value Pack (incl. 50ct) | OMNIS HEALTH | ||
| 47 | 00894030002482 | APX01GS0100-L | EmbraceEVO Gestational Diabetes Package - LARGE (9 vials) | OMNIS HEALTH | ||
| 48 | 00894030002475 | APX01GS0100-S | EmbraceEVO Gestational Diabetes Package - SMALL (5 vials) | OMNIS HEALTH | ||
| 49 | 00894030002420 | APX01AB0851 | Embrace EVO Mini Meter, all-in-one kit, RETAIL | OMNIS HEALTH | ||
| 50 | 00894030002406 | ALL02AB0202 | Embrace Pro Strips, 50-ct vials | OMNIS HEALTH |