Duns Number:002348191
Device Description: 15 Fr. 32 cm Edge(R) Hemodialysis CatheterizationSet, Long-Term Access Catheter Length, Cu 15 Fr. 32 cm Edge(R) Hemodialysis CatheterizationSet, Long-Term Access Catheter Length, Cuff to Tip: 27 cm
Catalog Number
CSD-15322-I
Brand Name
ARROW
Version/Model Number
IPN033110
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
a0aa46cd-b923-4f63-b5b9-59be98adbd01
Public Version Date
February 05, 2021
Public Version Number
5
DI Record Publish Date
October 16, 2015
Package DI Number
50801902096642
Quantity per Package
1
Contains DI Package
00801902096647
Package Discontinue Date
June 07, 2018
Package Status
Not 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 | 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 |