Duns Number:151810868
Device Description: Arriva Medical TRUE METRIX Blood Glucose Self Monitoring Meter
Catalog Number
RE4095-40
Brand Name
TRUE METRIX
Version/Model Number
TRUE METRIX Self Monitoring Blood Glucose Meter
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
November 07, 2017
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
73611510-a0cf-46cb-af2f-64dabb98b57d
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
May 05, 2017
Package DI Number
10021292007048
Quantity per Package
40
Contains DI Package
00021292007041
Package Discontinue Date
November 07, 2017
Package Status
Not 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 |