Duns Number:809699023
Device Description: PICC Convenience Kit
Catalog Number
-
Brand Name
Xcela
Version/Model Number
PKMR61010891S
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
K121990,K121990
Product Code
LJS
Product Code Name
Catheter,intravascular,therapeutic,long-term greater than 30 days
Public Device Record Key
81606d7b-6a74-43cb-9eee-0448adccce0c
Public Version Date
February 19, 2021
Public Version Number
4
DI Record Publish Date
November 08, 2016
Package DI Number
H965PKMR61010891S1
Quantity per Package
4
Contains DI Package
H965PKMR61010891S0
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 71 |
2 | A medical device with a moderate to high risk that requires special controls. | 1641 |