Duns Number:849626338
Device Description: SENSOR MMT-7020GA GS3 5PK US GC
Catalog Number
-
Brand Name
Guardian™ Sensor (3)
Version/Model Number
MMT-7020GA
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
Yes
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
P160007,P160007
Product Code
MDS
Product Code Name
Sensor, glucose, invasive
Public Device Record Key
2da7bf1e-ae89-4a0e-afca-3332d58231fe
Public Version Date
June 10, 2022
Public Version Number
3
DI Record Publish Date
June 22, 2019
Package DI Number
20763000179629
Quantity per Package
5
Contains DI Package
00763000179625
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
PK
| 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 |