Duns Number:141608724
Device Description: ACCU-CHEK GUIDE LINK REPLACEMENT KIT US
Catalog Number
-
Brand Name
Accu-Chek Guide Link
Version/Model Number
09015728001
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
P160017,P160017
Product Code
OZP
Product Code Name
Automated Insulin Dosing Device System, Single Hormonal Control
Public Device Record Key
763243d7-eaf7-4c29-8c86-cdab741bb794
Public Version Date
November 09, 2020
Public Version Number
1
DI Record Publish Date
October 30, 2020
Package DI Number
10365702738109
Quantity per Package
16
Contains DI Package
00365702738102
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 |