BEUDAMED

FDA UDI In Commercial Distribution 🇺🇸 United States

Affinity®

DI: 00643169178120 · Model: BB851 · MEDTRONIC, INC.

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Product Codes

1

GMDN Terms

1

Identifiers

2

Pkg Device Count

1

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Basic Information

Brand Name: Affinity®
Primary DI: 00643169178120
Version / Model: BB851
Company Name: MEDTRONIC, INC.
Labeler DUNS: 006261481
Distribution Status: In Commercial Distribution
Device Count in Pkg: 1
Record Status: Published
Publish Date: 2015-06-16
Public Version: 4
Public Version Date: 2024-10-07
Public Version Status: Update
Public Device Record Key: 24b3205b-2a9e-4a64-b72a-8d2dfc79a39e

Device Description

FILTER BB851 AF100 WITH BALANCE

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	20643169178124	GS1	PK	4	In Commercial Distribution
Primary	00643169178120	GS1

Customer Contacts

Phone: +1(800)633-8766
Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K122760	000

Storage Conditions

Type: Storage Environment Humidity
Temperature Range: 30 – 75 Percent (%) Relative Humidity
Type: Storage Environment Temperature
Temperature Range: -30 – 50 Degrees Celsius