Duns Number:016069284
Device Description: Blood Glucose Test Strips
Catalog Number
941
Brand Name
Pip
Version/Model Number
941
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
May 13, 2026
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K113208,K113208,K113208,K113208
Product Code
CGA
Product Code Name
Glucose Oxidase, Glucose
Public Device Record Key
213ad6d0-f9ff-4cd3-929b-ffb898491f2c
Public Version Date
April 11, 2022
Public Version Number
3
DI Record Publish Date
June 21, 2021
Package DI Number
10732671109412
Quantity per Package
50
Contains DI Package
00732671009418
Package Discontinue Date
May 13, 2026
Package Status
In Commercial Distribution
Package Type
Plastic Vial
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 5 |