Duns Number:313212471
Device Description: Accu-Chek Rapid-D 10/110 15+5+5pcs
Catalog Number
04541189001
Brand Name
Accu-Chek Rapid-D
Version/Model Number
04541189001
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 17, 2021
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
-
Product Code
FPA
Product Code Name
Set, Administration, Intravascular
Public Device Record Key
5fc85198-c932-4f64-8cff-b5606ba0200f
Public Version Date
September 20, 2021
Public Version Number
3
DI Record Publish Date
August 24, 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 |