Duns Number:849626338
Device Description: RSVR MMT-326A 10PK PDGM 1.8ML 2L 3YR UDI
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,K001828
Product Code
FRN
Product Code Name
Pump, infusion
Public Device Record Key
5b4cf3db-3c1a-480e-aace-f23a454703c2
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
October 03, 2016
Package DI Number
40643169771411
Quantity per Package
72
Contains DI Package
00643169771413
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CT
| 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 |