Duns Number:151810868
Device Description: Discount Drug Mart TRUE METRIX AIR Self Monitoring Blood Glucose Meter Kit box
Catalog Number
REA4025-01
Brand Name
TRUE METRIX AIR
Version/Model Number
TRUE METRIX AIR Self Monitoring Blood Glucose Meter
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)
Yes
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
5e7a04ae-b8fa-4e31-8d7d-ee0bffa601f4
Public Version Date
November 12, 2018
Public Version Number
3
DI Record Publish Date
November 10, 2016
Package DI Number
10093351022781
Quantity per Package
12
Contains DI Package
00093351022784
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 | 25 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 22 |