Quantum PureFlow Cardioplegia Heat Exchanger Low Flow 3/16 - PL

Basic Information

• Brand Name: Quantum PureFlow Cardioplegia Heat Exchanger Low Flow 3/16 - PL
• Primary DI: 08051160301256
• Version / Model: HX22W-C4
• Company Name: SPECTRUM MEDICAL SRL
• Labeler DUNS: 436188505
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-02-16
• Public Version: 3
• Public Version Date: 2024-01-05
• Public Version Status: Update
• Public Device Record Key: fe82ef3f-b541-4ee7-89bc-bd3ba04b7787

Device Characteristics

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

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DTR	Heat-Exchanger, Cardiopulmonary Bypass	Cardiovascular	870.4240	2

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	08051160301256	GS1

Premarket Submissions

Submission Number	Supplement Number
K212688	000
K220110	000