Paragon Adult Maxi PMP Oxygenator

Basic Information

• Brand Name: Paragon Adult Maxi PMP Oxygenator
• Primary DI: 05060491617915
• Version / Model: XCMOP405PMP
• Catalog Number: XCMOP405PMP
• Company Name: CHALICE MEDICAL LIMITED
• Labeler DUNS: 236289299
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-01-20
• Public Version: 1
• Public Version Date: 2021-01-28
• Public Version Status: New
• Public Device Record Key: abbb5db8-4cb1-4958-bf89-91968686b36c

Device Description

The Paragon Adult Maxi PMP oxygenator is a hollow fiber membrane oxygenator intended for physiologic gas exchange in adults and small adults undergoing cardiopulmonary bypass surgery. The integrated heat exchanger makes it possible to regulate the 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: Yes
• 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
DTZ	Oxygenator, Cardiopulmonary Bypass	Cardiovascular	870.4350	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	05060491617915	GS1
Package	15060491617912	GS1	BOX	12	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K191246	000

Device Sizes

Type	Value	Unit	Text
Total Volume	300	Milliliter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: to be stored in a dry, room temperature area and protected from direct solar or UV Light.