Duns Number:849626338
Device Description: PUMP MMT-1715KR 630G V4.11 JBL MG RECERT
Catalog Number
-
Brand Name
MiniMed® 630G
Version/Model Number
MMT-1715KR
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
P150001
Product Code
OZO
Product Code Name
Automated insulin dosing , threshold suspend
Public Device Record Key
124c7aa8-0ee6-4ecc-aefe-6e9bebe483c7
Public Version Date
November 04, 2019
Public Version Number
1
DI Record Publish Date
October 27, 2019
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 |