Duns Number:151810868
Device Description: TRUE METRIX AIR SELF MONITORING BLOOD GLUCOSE METER
Catalog Number
REA4H01-43
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
LFR
Product Code Name
Glucose Dehydrogenase, Glucose
Public Device Record Key
04dda087-6be6-4344-82c1-9320818b00b4
Public Version Date
November 12, 2018
Public Version Number
3
DI Record Publish Date
September 24, 2016
Package DI Number
10021292007918
Quantity per Package
40
Contains DI Package
00021292007911
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 |