Quantum SuperPAC Cardioplegia - Clamp System

Basic Information

• Brand Name: Quantum SuperPAC Cardioplegia - Clamp System
• Primary DI: 18051160303318
• Version / Model: SPCCPGD-D6
• Company Name: SPECTRUM MEDICAL SRL
• Labeler DUNS: 436188505
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-12-30
• Public Version: 1
• Public Version Date: 2026-01-07
• Public Version Status: New
• Public Device Record Key: f5b87354-f401-4a44-923d-459941359903

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• 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

GMDN Terms

Code	Name	Definition	Implantable	Status
64585	Cardiopulmonary bypass system heat exchanger, single-use	A device consisting of a heat exchanging system intended to be used in extracorporeal circulation to warm or cool the blood or perfusion fluid flowing through the device for the purposes of cardiopulmonary bypass intervention or treatment. This device will typically be a module of a cardiopulmonary bypass system whereby it receives thermal transfer fluid at a specific temperature from a system heating/cooling 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	18051160303318	GS1