Model: F32000015
DI: 04057224103778
Status: New
MRI: MR Unsafe
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-15
Current Version: 2026-05-25
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
186e08cd-967e-4090-abd9-5ef17b619729
Distribution Status:
In Commercial Distribution
DUNS Number:
341858364
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:
No
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
04057224103778
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 35441
Name: Cardiopulmonary bypass system blood tubing set
Definition:
A collection of sterile devices including tubing and typically clamps, filters, connectors, and stopcocks, used in a circuit for a cardiopulmonary bypass procedure. The tubing is typically polymeric and may be heparin coated. It is typically used in the blood pump head of a cardiopulmonary bypass system. The tubing, when used in a roller type pump, will be cyclically compressed by the blood pump to cause the blood to flow through the heart-lung bypass system. This is a single-use device.
FDA Product Codes
QJZ
Extracorporeal System For Long-Term Respiratory / Cardiopulmonary Failure
QWF
Tubing, Long Term Support Greater Than 6 Hours
BYS
Oxygenator, Long Term Support Greater Than 6 Hours
Premarket Submissions
Submission Number:
K232926
Supplement Number:
000