Duns Number:141608724
Device Description: ACCU-CHEK AVIVA PLUS HNP KIT 8/CASE
Catalog Number
07021941001
Brand Name
ACCU-CHEK AVIVA PLUS
Version/Model Number
07021941001
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
NBW
Product Code Name
System, Test, Blood Glucose, Over The Counter
Public Device Record Key
19208562-8420-4c94-a19b-04264a5c9e91
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
August 26, 2016
Package DI Number
10365702134109
Quantity per Package
8
Contains DI Package
00365702134102
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 |