Duns Number:656002163
Device Description: The WowGoHealth Blood Glucose Test Strip is for the measurement of glucose in whole blood. The WowGoHealth Blood Glucose Test Strip is for the measurement of glucose in whole blood. It is for In-vitro diagnostic use only. And the WowGoHealth test strips can only be used with WowGoHealth meter that has the same reference number.
Catalog Number
-
Brand Name
WowGoHealth Blood Glucose Test Strips - GSH-BGM902 - 2*25
Version/Model Number
GSH-BGM902 - 2*25
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
K141351,K141351,K141351,K141351
Product Code
LFR
Product Code Name
Glucose Dehydrogenase, Glucose
Public Device Record Key
560cdc4a-2839-48e3-b312-42526b78f2db
Public Version Date
July 12, 2019
Public Version Number
1
DI Record Publish Date
July 04, 2019
Package DI Number
24719878121129
Quantity per Package
10
Contains DI Package
04719878121125
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 |