Duns Number:849626338
Device Description: RSVR MMT-342 10PK EW 3ML PS ML US
Catalog Number
-
Brand Name
Extended Reservoir
Version/Model Number
MMT-342
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
K210714,K210714,K210714
Product Code
LZG
Product Code Name
Pump, infusion, insulin
Public Device Record Key
1d83679b-c671-4741-84f1-ce93f195e414
Public Version Date
September 19, 2022
Public Version Number
1
DI Record Publish Date
September 09, 2022
Package DI Number
40763000497482
Quantity per Package
72
Contains DI Package
20763000497181
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 |