Duns Number:960091929
Device Description: Glucertain Blood Glucose Test Strips, 25/vial, 2 vials/box, 260 boxes/case
Catalog Number
30150
Brand Name
Glucertain
Version/Model Number
30150
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
K112901,K112901,K112901,K112901
Product Code
LFR
Product Code Name
Glucose Dehydrogenase, Glucose
Public Device Record Key
b14a9ce0-c486-4aa6-9771-795b50021862
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
June 07, 2017
Package DI Number
B492301501
Quantity per Package
25
Contains DI Package
B492301500
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
vial
| 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 |