AFFINITY®

Basic Information

• Brand Name: AFFINITY®
• Primary DI: 00613994094346
• Version / Model: 61399409434
• Company Name: MEDTRONIC, INC.
• Labeler DUNS: 006261481
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-06-19
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: dc6ff15a-b898-41e7-be61-a8fbc5bbefbf

Device Description

FILTER 61399409434 AFFINITY 6CA ARFIL20M

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
DTM	Filter, blood, cardiopulmonary bypass, arterial line	Cardiovascular	870.4260	2

GMDN Terms

Code	Name	Definition	Implantable	Status
33309	Cardiopulmonary bypass system filter, arterial blood line	A sterile, porous device used in the arterial line of an extracorporeal circuit, during a cardiopulmonary bypass procedure, to trap and remove potentially harmful gaseous emboli, aggregated blood constituents, and particles greater than a specified size (e.g., 40 microns) to prevent them from flowing into the bloodstream and obstructing extracorporeal circulation. It is commonly referred to as a bubble trap and will typically be used for a specified length of time (e.g., 6 hours). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50613994094341	GS1	PK	6	In Commercial Distribution
Primary	00613994094346	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K994208	000

Device Sizes

Type	Value	Unit	Text
Pore Size	20.0	Micrometer

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: – 50 Degrees Celsius