Duns Number:062312574
Device Description: Blood Glucose Meter, CVS Health, Advanced, mg/dL
Catalog Number
-
Brand Name
CVS Health
Version/Model Number
8000-10291
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
-
Product Code
NBW
Product Code Name
System, Test, Blood Glucose, Over The Counter
Public Device Record Key
1b1b894b-f86e-4fb8-a230-e857a5e5be20
Public Version Date
December 03, 2018
Public Version Number
4
DI Record Publish Date
September 24, 2016
Package DI Number
10050428381714
Quantity per Package
12
Contains DI Package
00050428381717
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shipper
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 82 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 139 |
| U | Unclassified | 23 |