Duns Number:141608724
Device Description: Accu-Chek Compact Plus Control L2 (Bio)The UDI information was not placed on the vial labe Accu-Chek Compact Plus Control L2 (Bio)The UDI information was not placed on the vial label due to the new kit guidance that was published.
Catalog Number
-
Brand Name
Accu-Chek Compact Plus
Version/Model Number
06444393001
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 25, 2018
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
1ab23cb1-b4ee-41cf-8d9a-9b16d7c7da3c
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 |