Duns Number:141608724
Device Description: ACCU-CHEK SMART VIEW MED BEN STRIP 36/CS
Catalog Number
06337554001
Brand Name
ACCU-CHEK SMART VIEW
Version/Model Number
06337554001
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 06, 2018
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
c2e96866-6b4f-4cb8-8834-947db19b3987
Public Version Date
April 29, 2019
Public Version Number
3
DI Record Publish Date
August 08, 2016
Package DI Number
10365702494104
Quantity per Package
36
Contains DI Package
00365702494107
Package Discontinue Date
July 06, 2018
Package Status
Not 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 |