Duns Number:141608724
Device Description: ACCU-CHEK AVIVA EXPERT DEMO CUSTOMER PK
Catalog Number
07189486001
Brand Name
ACCU-CHEK AVIVA EXPERT
Version/Model Number
07189486001
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 17, 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
LFR
Product Code Name
Glucose Dehydrogenase, Glucose
Public Device Record Key
c5837977-06ee-4bd8-a7a4-9b9c9eafd6c8
Public Version Date
April 29, 2019
Public Version Number
3
DI Record Publish Date
August 26, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
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 |