| Primary Device ID | 34719878120020 |
| NIH Device Record Key | b347b348-ae28-41e1-8e53-335530791cd6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | WowGoHealth Blood Pressure Monitor GSH885B |
| Version Model Number | GSH885B |
| Company DUNS | 656002163 |
| Company Name | GOLDEN SMART HOME TECHNOLOGY CORP. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Phone | +88635770693 |
| service@goldensmarthome.com.tw |
| Height | 57.1 Millimeter |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04719878120029 [Primary] |
| GS1 | 34719878120020 [Package] Contains: 04719878120029 Package: Carton [24 Units] In Commercial Distribution |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2019-11-08 |
| Device Publish Date | 2019-05-17 |
| 04719878123518 - WowGoHealth Infrared Ear & Forehead Thermometer GSH-351 | 2023-04-05 The WowGoHealth Infrared Ear & Forehead Thermometer (Model GSH-351) is an infrared thermometer intended for the intermittent mea |
| 14719878122310 - WowGoHealth Bluetooth Body Fat Analyzer | 2021-06-01 The Body Fat Analyzer measures weight and estimate BMI and calories, and uses bio-electrical impedance analysis (BIA) technology |
| 04719878124027 - WowGoHealth Pulse Oximeter GSH601 | 2021-02-03 The pulse oximeter is a reusable device, and it’s intended for intermittent checks of oxygen saturation and pulse rate for adu |
| 34719878120037 - WowGoHealth Automatic Arm Bluetooth Blood Pressure Monitor | 2020-08-17 Automatic Arm Bluetooth Blood Pressure Monitor GSH862, intended to measure the systolic and diastolic blood pressure and pulse r |
| 04719878124010 - WowGoHealth Pulse Oximeter GSH601 | 2020-07-17 The pulse oximeter is a reusable device, and it’s intended for intermittent checks of oxygen saturation and pulse rate for adu |
| 14719878122020 - WowGoHealth Body Fat Analyzer GSH202-B | 2020-04-27 The Body Fat Analyzer measures weight and estimate BMI and calories, and uses bio-electrical impedance analysis (BIA) technology |
| 34719878120020 - WowGoHealth Blood Pressure Monitor GSH885B | 2019-11-08The WowGoHealth Blood Pressure Monitor GSH885B is digital monitors intended for use in measuring blood pressure and heartbeat rate with arm circumference ranging from 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. |
| 34719878120020 - WowGoHealth Blood Pressure Monitor GSH885B | 2019-11-08 The WowGoHealth Blood Pressure Monitor GSH885B is digital monitors intended for use in measuring blood pressure and heartbeat ra |
| 04719878120012 - WowGoHealth | 2019-11-08 The Blood Pressure Monitor LS802-B is digital monitor intended for use in measuring blood pressure and heartbeat rate in adult p |