Duns Number:960091929
Device Description: Glucertain Glucose Cntrol Solution, High, 50/box, 12 boxes/case
Catalog Number
30190
Brand Name
Glucertain
Version/Model Number
30190
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
-
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
K112901,K112901,K112901
Product Code
NBW
Product Code Name
System, Test, Blood Glucose, Over The Counter
Public Device Record Key
a5bffbf1-eb21-44b9-a8a0-a6eed88384d5
Public Version Date
December 07, 2018
Public Version Number
1
DI Record Publish Date
November 06, 2018
Package DI Number
30856276008827
Quantity per Package
12
Contains DI Package
20856276008820
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 | 59 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |
| U | Unclassified | 10 |