Duns Number:313212471
Device Description: Accu-Chek Aviva Combo Repl. mg (670)
Catalog Number
05458382001
Brand Name
Accu-Chek Combo
Version/Model Number
05458382001
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LZG
Product Code Name
Pump, Infusion, Insulin
Public Device Record Key
4cff3b8f-4acc-4136-b156-ae3803ae2d1e
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
August 25, 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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 16 |