Duns Number:141608724
Device Description: ACCU-CHEK COMPACT PLUS SAMPLE KIT 16/CS
Catalog Number
05907675001
Brand Name
ACCU-CHEK COMPACT PLUS
Version/Model Number
05907675001
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 31, 2017
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
K113614,K113614
Product Code
NBW
Product Code Name
System, Test, Blood Glucose, Over The Counter
Public Device Record Key
c9a732b6-40cd-4d00-9c38-5aa0a44ffef6
Public Version Date
April 29, 2019
Public Version Number
4
DI Record Publish Date
August 26, 2016
Package DI Number
10365702192109
Quantity per Package
16
Contains DI Package
00365702192102
Package Discontinue Date
December 31, 2017
Package Status
Not 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 |