Model: Perfusion Pack
DI: 00803622163340
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-04
Current Version: 2026-05-12
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
dba86076-c3e4-4ce7-99c0-1003772fac81
Distribution Status:
In Commercial Distribution
DUNS Number:
080914995
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:
CASE
Item #1 - Device ID:
10803622163347
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
5
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
00803622163340
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
00803622163340
Item #2 - Device ID Type:
Primary
Item #2 - Device ID 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
None