Duns Number:849626338
Device Description: STRT KIT MMT-7810N1 GST3C 2.1C ARM CD
Catalog Number
-
Brand Name
Guardian™ Link (3)
Version/Model Number
MMT-7810N1
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
Product Code
OZP
Product Code Name
Automated insulin dosing device system, single hormonal control
Public Device Record Key
40fcfd52-4bb4-4dfa-a825-6766060d6e9a
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
May 09, 2022
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 |