Duns Number:151810868
Device Description: TRUE METRIX GO Self Monitoring Blood Glucose Meter - Not For Retail Sale - Meter Only
Catalog Number
RF4H01-40
Brand Name
TRUE METRIX GO
Version/Model Number
TRUE METRIX GO Self Monitoring Blood Glucose Meter - NFRS
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 27, 2021
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
cd64d982-365a-46a8-bd23-fcc52543909c
Public Version Date
July 19, 2021
Public Version Number
4
DI Record Publish Date
April 13, 2017
Package DI Number
10021292009790
Quantity per Package
40
Contains DI Package
00021292009793
Package Discontinue Date
May 27, 2021
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 |