Duns Number:656002163
Device Description: The WowGoHealth Blood Glucose Monitoring System (Model GSH-BGM902) consists of the WowGoHe 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).
Catalog Number
-
Brand Name
WowGoHealth Blood Glucose Monitoring System GSH-BGM902
Version/Model Number
GSH-BGM902
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
Yes
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
K171785,K171785,K171785
Product Code
NBW
Product Code Name
System, Test, Blood Glucose, Over The Counter
Public Device Record Key
4b64fe94-320b-4cd8-8af4-d1c5c43e6232
Public Version Date
July 12, 2019
Public Version Number
1
DI Record Publish Date
July 04, 2019
Package DI Number
34719878121010
Quantity per Package
15
Contains DI Package
04719878121019
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Mid-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 |