Duns Number:688840958
Device Description: CareSens II Blood Glucose Monitoring System (Basic meter set)
Catalog Number
-
Brand Name
CareSens II
Version/Model Number
164221
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K080923,K080923
Product Code
NBW
Product Code Name
System, Test, Blood Glucose, Over The Counter
Public Device Record Key
29324cd6-b88e-42d7-8138-80a918fc9a76
Public Version Date
November 19, 2020
Public Version Number
1
DI Record Publish Date
November 11, 2020
Package DI Number
10885325001263
Quantity per Package
70
Contains DI Package
00885325001266
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Master Case Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 20 |