| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 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. | LFR | Glucose Dehydrogenase, Glucose | WowGoHealth Blood Glucose Test Strips - GSH-BGM902 - 2*25 | ||
| 2 | 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 | |
| 3 | 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 | |
| 4 | 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 | |
| 5 | 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 | |
| 6 | 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 | |
| 7 | 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 | |
| 8 | 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 | ||
| 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 | 10804084000010 | BPM 0001 | IDEAL LIFE BP-Manager™ | IDEAL LIFE INC | ||
| 2 | 10697038425621 | LD-753 | Welby | HONSUN (NANTONG) CO.,LTD | ||
| 3 | 10612479205298 | 1993 | BP Digital Cuff and Bladder, Adult | McKesson | MCKESSON MEDICAL-SURGICAL INC. | |
| 4 | 10612479205274 | 1992 | BP Digital Cuff and Bladder, Large, Adult | McKesson | MCKESSON MEDICAL-SURGICAL INC. | |
| 5 | 10610586038334 | 6120LA | BCI | SMITHS MEDICAL MD, INC. | ||
| 6 | 10610586036606 | 6004006 | BCI | SMITHS MEDICAL MD, INC. | ||
| 7 | 10610586036590 | 6004004 | BCI | SMITHS MEDICAL MD, INC. | ||
| 8 | 10610586036583 | 6004001 | BCI | SMITHS MEDICAL MD, INC. | ||
| 9 | 10610586036576 | 6004000 | BCI | SMITHS MEDICAL MD, INC. | ||
| 10 | M36811471 | 1147 | Advanced Wrist Blood Pressure Monitor | LUMISCOPE | GF HEALTH PRODUCTS, INC. | |
| 11 | M36811461 | 1146 | Digital Talking Wrist Blood Pressure Monitor | LUMISCOPE | GF HEALTH PRODUCTS, INC. | |
| 12 | M36811431 | 1143 | Automatic Wrist Blood Pressure Monitor | LUMISCOPE | GF HEALTH PRODUCTS, INC. | |
| 13 | M36811371 | 1137 | Advanced Upper Arm Blood Pressure Monitor | LUMISCOPE | GF HEALTH PRODUCTS, INC. | |
| 14 | M36811331 | 1133 | Automatic Blood Pressure Monitor | LUMISCOPE | GF HEALTH PRODUCTS, INC. | |
| 15 | M36811031 | 1103 | Semi-Automatic Blood Pressure Monitor | LUMISCOPE | GF HEALTH PRODUCTS, INC. | |
| 16 | 10193489012972 | MDSVSMSNTTP | MDSVSMSNTTP | DBD-MONITOR, BP, SPO2, EAR TEMP, PRINTER | Medline | MEDLINE INDUSTRIES, INC. |
| 17 | 10193489012965 | MDSVSMSNTT | MDSVSMSNTT | MONITOR, BP, SPO2, EAR TEMP | Medline | MEDLINE INDUSTRIES, INC. |
| 18 | 10193489012934 | MDSVSMSNTCP | MDSVSMSNTCP | DBD-MONITOR, BP, SPO2, ORAL TEMP, PRINTE | Medline | MEDLINE INDUSTRIES, INC. |
| 19 | 10193489012927 | MDSVSMSNTC | MDSVSMSNTC | MONITOR, BP, SPO2, ORAL TEMP | Medline | MEDLINE INDUSTRIES, INC. |
| 20 | 10193489012903 | MDSVSMN1 | MDSVSMN1 | MONITOR, BP, SPO2 | Medline | MEDLINE INDUSTRIES, INC. |
| 21 | 10080196721900 | MDS9973 | MDS9973 | CUFF,BP,EXTRA LARGE ADULT, FOR MDS3001 | Medline | MEDLINE INDUSTRIES, INC. |
| 22 | 10080196721856 | MDS9972 | MDS9972 | CUFF,BP,LARGE ADULT,FOR MDS3001 | Medline | MEDLINE INDUSTRIES, INC. |
| 23 | 10080196720286 | MDS9971 | MDS9971 | CUFF,BP,ADULT,FOR MDS3001 | Medline | MEDLINE INDUSTRIES, INC. |
| 24 | 10080196525188 | MDS3003 | MDS3003 | MONITOR,BP,WRIST,DIGITAL UNIT | Medline | MEDLINE INDUSTRIES, INC. |
| 25 | 10080196525140 | MDS3001 | MDS3001 | MONITOR,BP,AUTO,DIGITAL,ADULT | Medline | MEDLINE INDUSTRIES, INC. |
| 26 | 10080196170142 | MDS9133 | MDS9133 | ANEROID,HAND HELD,DUAL HD,STETH,HNT GRN | Medline | MEDLINE INDUSTRIES, INC. |
| 27 | 09351405001019 | BPPLUS-R7 | U10200 | Central Blood Pressure Device | BP+ | USCOM LIMITED |
| 28 | 09351337000098 | GM-800A | Arm Blood Pressure Monitor | GENERATION GUARD PTY LTD | ||
| 29 | 09351337000050 | GM-500W | Wrist Blood Pressure Monitor | GENERATION GUARD PTY LTD | ||
| 30 | 09120073932990 | V1.5 | 21-FHCN-15544 | Main Unit; | CNAP® Monitor 500 HD | CNSYSTEMS MEDIZINTECHNIK GMBH |
| 31 | 09120073932266 | V1.5 | 21-FHCN-15544 | Main Unit; | CNAP® Monitor 500 HD | CNSYSTEMS MEDIZINTECHNIK GMBH |
| 32 | 09120073932242 | V1.5 | 21-FHCN-15544 | Main Unit; including Quick Guide | CNAP® Monitor 500 HD | CNSYSTEMS MEDIZINTECHNIK GMBH |
| 33 | 09120073931948 | V1.0 | 1616 | Set of 4ECG electrodes, 3 ICG electrodes and one grounding pad | Set of electrodes | CNSYSTEMS MEDIZINTECHNIK GMBH |
| 34 | 09120073931825 | V1.5 | 21-FEZU-15401 | Unit; adapter between CNAP® controller and CNAP® forearm fixing cuff | Fixture for CNAP® controller | CNSYSTEMS MEDIZINTECHNIK GMBH |
| 35 | 09120073931764 | V1.2 | 21-FEZU-05010 | Unit; for fixing CNAP® Monitor on cart | CNAP® monitor mount - cart | CNSYSTEMS MEDIZINTECHNIK GMBH |
| 36 | 09120073931757 | V1.0 | 20-FEZU-15202 | Unit; for fixing CNAP® Monitor (GCX) | CNAP® monitor mount | CNSYSTEMS MEDIZINTECHNIK GMBH |
| 37 | 09120073931726 | V1.5 | 21-FHCN-15511 | Main Unit; include quick Guide | CNAP® Monitor 500 | CNSYSTEMS MEDIZINTECHNIK GMBH |
| 38 | 09120073931719 | V1.11 | 20-FEMA-05705 | Unit; for fixing the CNAP® controller | CNAP® forearm fixing cuff | CNSYSTEMS MEDIZINTECHNIK GMBH |
| 39 | 09120073931702 | V1.0 | 21-FHSG-02003 | Unit; for storage of CNAP® finger cuffs | CNAP® sensor organizer | CNSYSTEMS MEDIZINTECHNIK GMBH |
| 40 | 09120073931696 | V4.4 | 20-FVMA-15420I | Unit, with Infinity Lifecycle (1000h) | CNAP® double finger cuff "small" | CNSYSTEMS MEDIZINTECHNIK GMBH |
| 41 | 09120073931689 | V4.4 | 20-FVMA-15420U | Unit, with Unlimited Lifecycle (600h) | CNAP® double finger cuff "small" | CNSYSTEMS MEDIZINTECHNIK GMBH |
| 42 | 09120073931672 | V4.4 | 20-FVMA-15420 | Unit, with Standard Lifecycle (75h) | CNAP® double finger cuff "small" | CNSYSTEMS MEDIZINTECHNIK GMBH |
| 43 | 09120073931665 | V4.4 | 20-FVMA-15420M | Unit, with Maximum Lifecycle (300h) | CNAP® double finger cuff "small" | CNSYSTEMS MEDIZINTECHNIK GMBH |
| 44 | 09120073931658 | V4.4 | 20-FVMA-15520I | Unit, with Infinity Lifecycle (1000h) | CNAP® double finger cuff "medium" | CNSYSTEMS MEDIZINTECHNIK GMBH |
| 45 | 09120073931641 | V4.4 | 20-FVMA-15520U | Unit, with Unlimited Lifecycle (600h) | CNAP® double finger cuff "medium" | CNSYSTEMS MEDIZINTECHNIK GMBH |
| 46 | 09120073931634 | V4.4 | 20-FVMA-15520 | Unit, with Standard Lifecycle (75h) | CNAP® double finger cuff "medium" | CNSYSTEMS MEDIZINTECHNIK GMBH |
| 47 | 09120073931627 | V4.4 | 20-FVMA-15520M | Unit, with Maximum Lifecycle (300h) | CNAP® double finger cuff "medium" | CNSYSTEMS MEDIZINTECHNIK GMBH |
| 48 | 09120073931610 | V4.4 | 20-FVMA-15620I | Unit, with Infinity Lifecycle (1000h) | CNAP® double finger cuff "large" | CNSYSTEMS MEDIZINTECHNIK GMBH |
| 49 | 09120073931603 | V4.4 | 20-FVMA-15620U | Unit, with Unlimited Lifecycle (600h) | CNAP® double finger cuff "large" | CNSYSTEMS MEDIZINTECHNIK GMBH |
| 50 | 09120073931597 | V4.4 | 20-FVMA-15620 | Unit, with Standard Lifecycle (75h) | CNAP® double finger cuff "large" | CNSYSTEMS MEDIZINTECHNIK GMBH |