Quantum Perfusion Centrifugal Blood Pump CP20

Basic Information

• Brand Name: Quantum Perfusion Centrifugal Blood Pump CP20
• Primary DI: 18051160302144
• Version / Model: CP20V-V0U
• Company Name: SPECTRUM MEDICAL SRL
• Labeler DUNS: 436188505
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-06-27
• Public Version: 2
• Public Version Date: 2024-01-05
• Public Version Status: Update
• Public Device Record Key: 1bc76cd0-b13b-4f11-ad54-8439d11528b8

Device Characteristics

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

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KFM	Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type	Cardiovascular	870.4360	2

GMDN Terms

Code	Name	Definition	Implantable	Status
31718	Cardiopulmonary bypass system centrifugal pump	A device intended to be connected to a drive unit (not included) to circulate blood through the extracorporeal circuit of a non-roller type cardiopulmonary bypass system, via a centrifugal force mechanism, for gas exchange and reinfusion; it may in addition be used in extracorporeal support systems for ventricular support/circulatory assistance. It includes flow channels and a rotor driven by the system’s drive unit. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	18051160302144	GS1

Premarket Submissions

Submission Number	Supplement Number
K220842	000