Affinity®

Basic Information

• Brand Name: Affinity®
• Primary DI: 00613994529107
• Version / Model: CB541
• Company Name: MEDTRONIC, INC.
• Labeler DUNS: 006261481
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-06-16
• Public Version: 5
• Public Version Date: 2020-01-22
• Public Version Status: Update
• Public Device Record Key: 15444f96-93fe-465f-a506-e1313e2f3466
• Distribution End Date: 2018-10-05

Device Description

OXYGENATOR CB541 AFFINITY US 2PK

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: No
• Has Expiration Date: No
• 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
Package	20613994529101	GS1	PK	2	Not in Commercial Distribution	2018-10-05
Primary	00613994529107	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K000430	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: – 40 Degrees Celsius