Cardiovascular Procedure Kit

Basic Information

• Brand Name: Cardiovascular Procedure Kit
• Primary DI: 00699753536784
• Version / Model: CX-FL047X
• Company Name: Terumo Cardiovascular Systems Corporation
• Labeler DUNS: 177655466
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-12-10
• Public Version: 1
• Public Version Date: 2025-12-18
• Public Version Status: New
• Public Device Record Key: a18a71e7-f77b-41a0-b82c-4ceb2659f6b6

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

GMDN Terms

Code	Name	Definition	Implantable	Status
35441	Cardiopulmonary bypass system blood tubing set	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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50699753536789	GS1	6 PIECE CASE	6	In Commercial Distribution
Primary	00699753536784	GS1