Duns Number:849626338
Device Description: RSVR MMT-326A 10PK PRDGM 21L INTL 3YR OL
Catalog Number
-
Brand Name
MiniMed™ Reservoir
Version/Model Number
MMT-326A
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
Yes
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
K001828,K001828
Product Code
FRN
Product Code Name
Pump, infusion
Public Device Record Key
6ea6d77b-d58f-49ed-b847-97aaa529633d
Public Version Date
September 10, 2019
Public Version Number
1
DI Record Publish Date
September 02, 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 |