Duns Number:849626338
Device Description: SERTER MMT-305QS QUICKSERTER QUICKSET
Catalog Number
-
Brand Name
MiniMed™ Quick-serter™
Version/Model Number
MMT-305QS
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
K160860
Product Code
KZH
Product Code Name
INTRODUCER, SYRINGE NEEDLE
Public Device Record Key
cd4e842b-0430-4622-a3f9-3c1323c9145e
Public Version Date
August 15, 2022
Public Version Number
2
DI Record Publish Date
June 14, 2020
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 |