Duns Number:141608724
Device Description: ACCU-CHEK COMPACT PLUS CARE KIT 8/CASE
Catalog Number
-
Brand Name
ACCU-CHEK COMPACT PLUS
Version/Model Number
03149137001
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 23, 2019
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
NBW
Product Code Name
System, Test, Blood Glucose, Over The Counter
Public Device Record Key
3399ffe1-79b4-4c2d-a1e9-6adb1f5e7eef
Public Version Date
December 24, 2019
Public Version Number
3
DI Record Publish Date
August 26, 2016
Package DI Number
10075537490706
Quantity per Package
8
Contains DI Package
00075537490709
Package Discontinue Date
December 23, 2019
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 |