Duns Number:141608724
Device Description: ACCU-CHEK INFORM II US 50CT 36/CS F2
Catalog Number
05942861001
Brand Name
ACCU-CHEK INFORM II
Version/Model Number
05942861001
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LFR
Product Code Name
Glucose Dehydrogenase, Glucose
Public Device Record Key
99651431-8e42-4d72-b13e-8ed2133ea48a
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
August 26, 2016
Package DI Number
10365702428109
Quantity per Package
36
Contains DI Package
00365702428102
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 63 |
| 3 | A medical device with high risk that requires premarket approval | 3 |