Model: SD-G01
DI: 04711552764666
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: No
OTC: No
First Published: 2026-04-24
Current Version: 2026-05-04
Description
S-01-G2R-C-05
Sterilization
Method Types - Sterilization Method:
Ethylene Oxide
Device Sterile:
Yes
Sterilization Prior To Use:
Yes
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
677e62aa-fa76-4c08-9a94-5b5173eaa7bd
Distribution Status:
In Commercial Distribution
DUNS Number:
657715348
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
04711552764666
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 34999
Name: Haemodialysis blood tubing set, single-use
Definition:
A collection of tubing segments and associated devices (e.g., connectors, clamps) intended to be used to transfer blood between a patient's vascular access device and a haemodialyser during haemodialysis; it is sometimes referred to as haemodialysis blood lines. This is a single-use device.
FDA Product Codes
FJK
Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
Premarket Submissions
Submission Number:
K014140
Supplement Number:
000