Model: BB12F59R1
DI: 00199150080021
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-01
Current Version: 2026-05-11
Description
CUSTOM PACK BB12F59R1 4PK CPG FAIRVIEW
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
5967f778-c34a-4005-a872-9ecdb73f3590
Distribution Status:
In Commercial Distribution
DUNS Number:
006261481
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:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Item #1 - Pkg Type:
PK
Item #1 - Device ID:
20199150080032
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
4
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
00199150080021
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
00199150080021
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
DWF
Catheter, cannula and tubing, vascular, cardiopulmonary bypass
Premarket Submissions
Submission Number:
K171979
Supplement Number:
000
Environmental Conditions
Storage Handling - Storage Handling Low - @attributes - Unit:
Degrees Celsius
Storage Handling - Storage Handling High - @attributes - Unit:
Degrees Celsius
Storage Handling - Storage Handling High - @attributes - Value:
50
Storage Handling - Storage Handling Type:
Storage Environment Temperature