Duns Number:141608724
Device Description: ACCU-CHEK AVIVA PLUS SAMPLE KIT 16/CASE
Catalog Number
06988563001
Brand Name
ACCU-CHEK AVIVA PLUS
Version/Model Number
06988563001
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 14, 2019
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
NBW
Product Code Name
System, Test, Blood Glucose, Over The Counter
Public Device Record Key
4cb7d8d3-900d-40b8-a08a-8ef026d0fb67
Public Version Date
May 15, 2019
Public Version Number
3
DI Record Publish Date
August 26, 2016
Package DI Number
10365702445106
Quantity per Package
16
Contains DI Package
00365702445109
Package Discontinue Date
May 14, 2019
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 |