Duns Number:849626338
Device Description: MONITOR MMT-9101 MYSNTRY1 V1.1 EN
Catalog Number
-
Brand Name
mySentry™
Version/Model Number
MMT-9101
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 15, 2016
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
P980022
Product Code
CGA
Product Code Name
GLUCOSE OXIDASE, GLUCOSE
Public Device Record Key
d9438ca8-637d-41ec-b7ad-20767c9bead1
Public Version Date
November 10, 2021
Public Version Number
6
DI Record Publish Date
September 23, 2014
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 29 |
| 3 | A medical device with high risk that requires premarket approval | 1084 |