Duns Number:141608724
Device Description: Accu-Chek Guide Retail Kit FCN mg/dl US
Catalog Number
-
Brand Name
Accu-Chek Guide
Version/Model Number
08453071001
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
K160944,K160944
Product Code
NBW
Product Code Name
System, Test, Blood Glucose, Over The Counter
Public Device Record Key
f196d983-7c22-4b77-9339-b84b2287330a
Public Version Date
July 06, 2018
Public Version Number
2
DI Record Publish Date
March 02, 2018
Package DI Number
10365702729107
Quantity per Package
10
Contains DI Package
00365702729100
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 |