Duns Number:141608724
Device Description: Accu-Chek Fastclix AST Kit USA
Catalog Number
07531567160
Brand Name
Accu-Chek Fastclix
Version/Model Number
07531567160
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
QRL
Product Code Name
Multiple Use Blood Lancet For Single Patient Use Only
Public Device Record Key
6d4346c3-e04d-4f57-b380-ce14700dc3a1
Public Version Date
October 05, 2022
Public Version Number
1
DI Record Publish Date
September 27, 2022
Package DI Number
10365702702216
Quantity per Package
100
Contains DI Package
00365702702219
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 |