Duns Number:849626338
Device Description: SENSOR MMT-7020PLA GS3 5PK 2L US
Catalog Number
-
Brand Name
Guardian™ Sensor (3)
Version/Model Number
MMT-7020PLA
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
P160017,P160017
Product Code
OZP
Product Code Name
Automated insulin dosing device system, single hormonal control
Public Device Record Key
5f0faea6-e9a8-4445-bcc4-ed2ec247bd66
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
October 31, 2020
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 |