Duns Number:656002163
Device Description: The pulse oximeter is a reusable device, and it’s intended for intermittent checks of oxyg 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.
Catalog Number
Gray
Brand Name
WowGoHealth Pulse Oximeter GSH601
Version/Model Number
GSH601
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
-
Product Code
OCH
Product Code Name
Oximeter, Infrared, Sporting, Aviation
Public Device Record Key
fc26093e-94cb-4fa2-b94d-89389f04fd29
Public Version Date
November 10, 2021
Public Version Number
3
DI Record Publish Date
July 09, 2020
Package DI Number
14719878124017
Quantity per Package
10
Contains DI Package
04719878124010
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| 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 |