Affinity Pixie™

Basic Information

• Brand Name: Affinity Pixie™
• Primary DI: 00613994617255
• Version / Model: CBP241
• 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: 2022-09-22
• Public Version Status: Update
• Public Device Record Key: 2d4bf061-398c-443d-8475-5a04d7b4d2cf
• Distribution End Date: 2019-10-21

Device Description

OXYGENATOR CBP241 W/CVR NI CB STERIL NCE

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
31710	Cardiotomy reservoir	A device intended to be integrated within an extracorporeal circuit to collect, store, and filter blood typically during a cardiopulmonary bypass procedure; it does not include additional functional components such as an oxygenator. It is typically a hardshell or soft, bag-like container with connectors designed to trap micro-particles and air bubbles for a period of time (e.g., 6 hours) and hold a reserve supply of blood; some types may also defoam. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20613994617259	GS1	PK	4	Not in Commercial Distribution	2019-10-21
Primary	00613994617255	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K100645	000

Storage Conditions

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