Duns Number:849626338
Device Description: CHARGER MMT-7715 MDR GST3 21L IIN
Catalog Number
-
Brand Name
Charger
Version/Model Number
MMT-7715
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
P120010
Product Code
OZP
Product Code Name
Automated insulin dosing device system, single hormonal control
Public Device Record Key
563f4a01-9839-4065-aa5d-fbdd3aaa6d35
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
February 20, 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 |