Duns Number:141608724
Device Description: ACCU-CHEK AVIVA PLUS 100CT STRP BRK 24/C
Catalog Number
06908268001
Brand Name
ACCU-CHEK AVIVA PLUS
Version/Model Number
06908268001
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
061ddcb0-84e7-4a31-b38c-0437ae9f59f3
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
August 26, 2016
Package DI Number
10365702408101
Quantity per Package
24
Contains DI Package
00365702408104
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 |