Adult Tubing Pack with Paragon Adult Maxi PMP Oxygenator

Basic Information

• Brand Name: Adult Tubing Pack with Paragon Adult Maxi PMP Oxygenator
• Primary DI: 05060491614129
• Version / Model: CME40004
• Catalog Number: CME40004
• Company Name: CHALICE MEDICAL LIMITED
• Labeler DUNS: 236289299
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-11-07
• Public Version: 2
• Public Version Date: 2024-01-03
• Public Version Status: Update
• Public Device Record Key: 5ec173ca-873b-4257-9a10-15f37cd39656

Device Description

The Adult Tubing Pack with Paragon Adult Maxi PMP Oxygenator is intended for use in extracorporeal circulation during cardiopulmonary bypass procedures, lasting 6 hours or less.

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
DTR	Heat-Exchanger, Cardiopulmonary Bypass	Cardiovascular	870.4240	2
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	870.4210	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62085	Extracorporeal membrane oxygenation system circuit	A complete portable assembly of noninvasive, non-powered devices intended to be used as part of an extracorporeal bypass system to provide short-term or prolonged (i.e., extra-surgical) mechanical circulatory life support during extracorporeal membrane oxygenation (ECMO) [sometimes referred to as extracorporeal lung support (ECLS)]. It usually includes a centrifugal pump mechanism, defoamer, heat exchanger, membrane oxygenator, and integrated tubing or independent tubing sets. It is intended to be used in conjunction with the capital components (e.g., pump drive unit, gas control unit, heating/cooling unit) and invasive components (e.g., cannulae) of the bypass. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	15060491614126	GS1	BOX	3	In Commercial Distribution
Primary	05060491614129	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K201642	000

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.