Model: CS-15422-VFIE
Catalog: CS-15422-VFIE
DI: 10801902154306
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-04-30
Current Version: 2026-05-08
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
ce7b1559-1682-4b3e-bbea-b162184e731c
Distribution Status:
In Commercial Distribution
DUNS Number:
002348191
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
Yes
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Item #1 - Pkg Type:
BX
Item #1 - Device ID:
20801902154303
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
1
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
10801902154306
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
10801902154306
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
Item #3 - Pkg Type:
CS
Item #3 - Device ID:
30801902154300
Item #3 - Pkg Status:
In Commercial Distribution
Item #3 - Pkg Quantity:
1
Item #3 - Device ID Type:
Package
Item #3 - Contains DINumber:
20801902154303
Item #3 - Device ID Issuing Agency:
GS1
GMDN
Code: 37278
Name: Double-lumen haemodialysis catheter, implantable
Definition:
An implantable, flexible, double-lumen tube intended to be used for chronic or long-term (> 30 days) vascular access, primarily during haemodialysis, to conduct blood from a patient and returning it after extracorporeal circulation; it may also be used during haemoperfusion and/or apheresis. It is intended for coaxial flow of blood, may be radiopaque, coated with heparin to prevent thrombus formation, and/or include a silver-coated sleeve to retard bacterial growth; devices dedicated to catheter introduction/function (e.g., introducer needle) may be included.
FDA Product Codes
MSD
Catheter, hemodialysis, implanted
Premarket Submissions
Submission Number:
K141051
Supplement Number:
000
Environmental Conditions
Storage Handling - Storage Handling Low - @attributes - Unit:
Degrees Celsius
Storage Handling - Storage Handling Low - @attributes - Value:
15
Storage Handling - Storage Handling High - @attributes - Unit:
Degrees Celsius
Storage Handling - Storage Handling High - @attributes - Value:
25
Storage Handling - Storage Handling Type:
Storage Environment Temperature