Duns Number:044611812
Device Description: Port Access Kit
Catalog Number
CPA00041A
Brand Name
MiniLoc
Version/Model Number
CPA00041A
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"
Yes
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FPA
Product Code Name
Set, administration, intravascular
Public Device Record Key
92cbc737-d820-43e6-b0b8-a149885a8736
Public Version Date
October 23, 2019
Public Version Number
2
DI Record Publish Date
November 13, 2018
Package DI Number
10801741182959
Quantity per Package
5
Contains DI Package
00801741182952
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CA
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 36 |
2 | A medical device with a moderate to high risk that requires special controls. | 3348 |
U | Unclassified | 8 |