Duns Number:313212471
Device Description: Accu-Chek Ultraflex I 6/60 10pcs
Catalog Number
06593976001
Brand Name
Accu-Chek Ultraflex
Version/Model Number
06593976001
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
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K122686,K122686
Product Code
FPA
Product Code Name
Set, Administration, Intravascular
Public Device Record Key
f24908f8-50c2-443d-81ae-7288391d8732
Public Version Date
July 06, 2018
Public Version Number
4
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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 16 |