Duns Number:656002163
Device Description: The WowGoHealth Blood Pressure Monitor GSH885B is digital monitors intended for use in mea 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.
Catalog Number
-
Brand Name
WowGoHealth Blood Pressure Monitor GSH885B
Version/Model Number
GSH885B
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K131395,K131395
Product Code
DXN
Product Code Name
System, Measurement, Blood-Pressure, Non-Invasive
Public Device Record Key
b347b348-ae28-41e1-8e53-335530791cd6
Public Version Date
November 08, 2019
Public Version Number
2
DI Record Publish Date
May 17, 2019
Package DI Number
34719878120020
Quantity per Package
24
Contains DI Package
04719878120029
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 5 |