Duns Number:141608724
Device Description: ACCU-CHEK AVIVA PLUS 50 MED-BEN BRK 36/C
Catalog Number
06908314001
Brand Name
ACCU-CHEK AVIVA PLUS
Version/Model Number
06908314001
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 12, 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
aae6013e-ff19-4e91-b0f9-8e442adc6344
Public Version Date
April 29, 2019
Public Version Number
3
DI Record Publish Date
August 26, 2016
Package DI Number
10365702437101
Quantity per Package
36
Contains DI Package
00365702437104
Package Discontinue Date
June 12, 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 |