Duns Number:941150349
Device Description: Blood glucose test cartridges with 10 tests per cartridge. Five cartridges per tube (50 te Blood glucose test cartridges with 10 tests per cartridge. Five cartridges per tube (50 tests)
Catalog Number
00856176008056
Brand Name
POGO Automatic Test Cartridges
Version/Model Number
00856176008056
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
-
Product Code
NBW
Product Code Name
System, Test, Blood Glucose, Over The Counter
Public Device Record Key
77fbd2bc-40bb-4f12-abe0-fa385c93e643
Public Version Date
September 16, 2021
Public Version Number
2
DI Record Publish Date
February 02, 2020
Package DI Number
50856176008051
Quantity per Package
12
Contains DI Package
00856176008056
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2 |