Duns Number:849626338
Device Description: PUMP MMT-1715KL 630G V4.11 JBL MG
Catalog Number
-
Brand Name
MiniMed® 630G
Version/Model Number
MMT-1715KL
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)
Yes
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
79df16b5-ba44-40a8-b92a-0cbed834d8c1
Public Version Date
June 03, 2019
Public Version Number
1
DI Record Publish Date
May 25, 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 |