Duns Number:002348191
Device Description: 15 Fr. x 50 cm Edge(R) Hemodialysis Catheter(.) Long-Term Access. Catheter Length, Tip to 15 Fr. x 50 cm Edge(R) Hemodialysis Catheter(.) Long-Term Access. Catheter Length, Tip to Cuff: 50 cm
Catalog Number
AC-15502-ICO
Brand Name
ARROW
Version/Model Number
IPN032584
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K111117,K111117,K111117
Product Code
MSD
Product Code Name
Catheter, hemodialysis, implanted
Public Device Record Key
004d5fb0-8147-4e45-b5b9-d21cac4fba67
Public Version Date
February 05, 2021
Public Version Number
5
DI Record Publish Date
October 16, 2015
Package DI Number
30801902096037
Quantity per Package
1
Contains DI Package
10801902096033
Package Discontinue Date
January 10, 2019
Package Status
Not in Commercial Distribution
Package Type
Case
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 3195 |
2 | A medical device with a moderate to high risk that requires special controls. | 13747 |
3 | A medical device with high risk that requires premarket approval | 3 |
U | Unclassified | 26 |