Duns Number:023904428
Device Description: METER KIT, BLD GLUC TRUEMETRIX
Catalog Number
-
Brand Name
McKesson
Version/Model Number
06-RE4051-43
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"
Yes
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
12b74a9f-6853-4af2-90bc-fd8a6609fe74
Public Version Date
September 09, 2020
Public Version Number
3
DI Record Publish Date
December 09, 2016
Package DI Number
40612479197242
Quantity per Package
6
Contains DI Package
20612479197231
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 870 |
2 | A medical device with a moderate to high risk that requires special controls. | 422 |
U | Unclassified | 44 |