Quadrox-i

Basic Information

• Brand Name: Quadrox-i
• Primary DI: 04058863017792
• Version / Model: SQUADROX-i HMO 70000+ VHK7000
• Catalog Number: 70106.7941
• Company Name: Maquet Cardiopulmonary AG
• Labeler DUNS: 316153865
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-03-13
• Public Version: 5
• Public Version Date: 2020-06-16
• Public Version Status: Update
• Public Device Record Key: 405a4a7a-46fb-492c-bb2a-29ed8250f487
• Distribution End Date: 2020-06-15

Device Description

Quadrox-i Hollow Membrane Oxygenator, Adult, with VHK Reservior, unsealed, with Universal Adaptor, without Filter; vacuum-tight, non-Coated, Sterile. The QUADROX-i Adult oxygenators are blood-gas exchangers with integrated heat exchanger and optionally integrated arterial blood filter. They are used in cardiac surgery, in combination with a heart-lung machine, to oxygenate blood, remove carbon dioxide and adjust blood temperature.

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: 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: 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
GOD	Antigens, Cf (Including Cf Control), Adenovirus 1-33	Microbiology	866.3020	1
DTP	Defoamer, Cardiopulmonary Bypass	Cardiovascular	870.4230	2
DTN	Reservoir, Blood, Cardiopulmonary Bypass	Cardiovascular	870.4400	2

GMDN Terms

Code	Name	Definition	Implantable	Status
17643	Extracorporeal membrane oxygenator	A device designed for the extracorporeal diffusion of oxygen into blood across a gas-permeable membrane during a cardiopulmonary bypass or extracorporeal membrane oxygenation procedure. It includes a membrane that separates a thin layer of blood from the oxygenating gas; oxygen diffuses from the gas compartment into the blood, while carbon dioxide diffuses from the blood through the membrane and is flushed out of the oxygenator by the oxygen flow. The device may include an integrated heat exchanger, arterial filter, or cardiotomy/venous reservoir. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04058863017792	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K132166	000

Device Sizes

Type	Value	Unit	Text
Total Volume	335	Milliliter
Weight	2.930	Kilogram