Affinity Pixie™

GUDID 20613994617310

OXYGENATOR BBP211 NI BB STERILE

MEDTRONIC, INC.

Extracorporeal membrane oxygenator

• Primary Device ID: 20613994617310
• NIH Device Record Key: bfb1e06b-77ce-45e0-b324-b3bee9c0177a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Affinity Pixie™
• Version Model Number: BBP211
• Company DUNS: 006261481
• Company Name: MEDTRONIC, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00613994617316 [Primary]
GS1	20613994617310 [Package]; Contains: 00613994617316; Package: PK [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100645

FDA Product Code

• DTZ: OXYGENATOR, CARDIOPULMONARY BYPASS

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-01-22
• Device Publish Date: 2015-06-16

On-Brand Devices [Affinity Pixie™]

• 20613994617327: ARTERIAL FILTER BB4014PEDS BB STERILE
• 20613994617310: OXYGENATOR BBP211 NI BB STERILE
• 20613994617303: OXYGENATOR BBP241 W/CVR NI BB STERILE
• 20613994617273: OXYGENATOR CBP211 NI CB STERILE NCE
• 20613994617259: OXYGENATOR CBP241 W/CVR NI CB STERIL NCE
• 20643169878123: ARTERIAL FILTER BB4014PEDS BB STERILE
• 20643169785827: OXYGENATOR CBP241 W/CVR PIXIE CB 4PK US
• 20643169785803: OXYGENATOR CBP211 PIXIE CORTIVA 4PK US
• 20643169767724: FILTER CB4014 AFF PED ART CC ST CEM 4PK