FDA UDI
In Commercial Distribution
🇺🇸 United States
WowGoHealth Blood Pressure Monitor GSH885B
DI: 04719878120029
·
Model: GSH885B
·
GOLDEN SMART HOME TECHNOLOGY CORP.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- WowGoHealth Blood Pressure Monitor GSH885B
- Primary DI
- 04719878120029
- Version / Model
- GSH885B
- Company Name
- GOLDEN SMART HOME TECHNOLOGY CORP.
- Labeler DUNS
- 656002163
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-05-17
- Public Version
- 2
- Public Version Date
- 2019-11-08
- Public Version Status
- Update
- Public Device Record Key
- b347b348-ae28-41e1-8e53-335530791cd6
Device Description
The 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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | Cardiovascular | 870.1130 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45617 | Automatic-inflation electronic sphygmomanometer, portable, arm/wrist | An electrically-powered device designed to noninvasively measure blood pressure using a self-contained software program that regulates automatic arm/wrist-cuff inflation and measurement cycles. It typically displays current heart rate and mean arterial pressure in addition to systolic and diastolic blood pressures; it may have memory to store blood pressure values and may sound an alarm if blood pressure exceeds pre-set limits. This device is designed to be portable (e.g., hand-held or carried in a pouch) and is often used for emergency services or home blood pressure monitoring. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 34719878120020 | GS1 | Carton | 24 | In Commercial Distribution | |
| Primary | 04719878120029 | GS1 |
Customer Contacts
- Phone
- +88635770693
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K131395 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 154 | Millimeter | |
| Width | 106 | Millimeter | |
| Height | 57.1 | Millimeter |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 5 – 40 Degrees Celsius
- Type
- Handling Environment Humidity
- Temperature Range
- 15 – 90 Percent (%) Relative Humidity
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 70 – 106 KiloPascal
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 60 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 0 – 93 Percent (%) Relative Humidity