Duns Number:047047543
Device Description: MINIMED 24IN PCAP MMT-280
Catalog Number
328614
Brand Name
Medtronic MiniMed Pro-Set Infusion Set, PCAP Connection 24in
Version/Model Number
328614
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K160651,K160651,K160651
Product Code
FPA
Product Code Name
Set, administration, intravascular
Public Device Record Key
92de8c0b-bcf3-47fb-b3a2-3ad32a108cc9
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
August 03, 2016
Package DI Number
50382903286145
Quantity per Package
15
Contains DI Package
00382903286140
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 5 |