Quantum

Basic Information

• Brand Name: Quantum
• Primary DI: 05060434423832
• Version / Model: 52-000096-00
• Catalog Number: 52-000096-00
• Company Name: SPECTRUM MEDICAL LIMITED
• Labeler DUNS: 516398679
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2022-10-25
• Public Version: 1
• Public Version Date: 2022-11-02
• Public Version Status: New
• Public Device Record Key: 09576f62-030a-4e02-b39b-563e05ff2302

Device Description

IRMA Adaptor Kit

Device Characteristics

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

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DTX	Gas Control Unit, Cardiopulmonary Bypass	Cardiovascular	870.4300	2

GMDN Terms

Code	Name	Definition	Implantable	Status
31714	Cardiopulmonary bypass system gas control unit	A device that is a module of a cardiopulmonary bypass system and that is used to control and measure the flow of gas supplied into the oxygenator. It is calibrated for a specific gas and has a high degree of accuracy at low flows. It may be a flowmeter.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	15060434423839	GS1
Primary	05060434423832	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]
• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K181942	000

Storage Conditions

• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 76 – 106 KiloPascal
• Type: Handling Environment Humidity
• Temperature Range: 0 – 90 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 0 – 60 Degrees Celsius