AFFINITY®

GUDID 20613994375678

OXYGENATOR 95212 AFFINITY NT 511 4/B 4PK

MEDTRONIC, INC.

Extracorporeal membrane oxygenator

• Primary Device ID: 20613994375678
• NIH Device Record Key: 2eb335da-26fd-4ca0-8972-5345add163f0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AFFINITY®
• Version Model Number: 95212
• 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: false
• 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
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• 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
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• 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	00613994375674 [Primary]
GS1	20613994375678 [Package]; Contains: 00613994375674; Package: PK [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191029
• Premarket Notification: K932252

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: 2015-06-18

On-Brand Devices [AFFINITY®]

• 00613994803177: PROBE ATP210 AFFINITY TEMPERATURE WW
• 20613994529101: OXYGENATOR CB541 AFFINITY US 2PK
• 20613994529095: OXYGENATOR CB511 AFFINITY BIOACT US 4PK
• 20613994404897: FILTER CB4014 AFF PED ART CC ST CEM 4PK
• 20613994375678: OXYGENATOR 95212 AFFINITY NT 511 4/B 4PK
• 20613994375654: OXYGENATOR 95214 AFFINITY 2PK 541
• 20613994309338: FILTER S4014 AFFINITYPEDIATRIC ART ST
• 50613994094341: FILTER 61399409434 AFFINITY 6CA ARFIL20M
• 50613994011539: FILTER 61399401153 AFFINITY 6CA ART 352
• 50613994011249: FILTER 61399401124 AFFINITY 6CA ART 351
• 00643169778177: PROBE ATP210 AFFINITY TEMPERATURE
• 20643169178124: FILTER BB851 AF100 WITH BALANCE
• 20643169178032: FILTER CB851 AF100 WITH CARMEDA
• 20681490008574: OXYGENATOR CB511 AFFINITY BIOACT
• 20681490008536: FILETR CB353 BIOAC 20M AFFINITY
• 20681490008529: FILTER CB351 ART 38M 6/B 6PK
• 20681490008024: FILTER 61399409503 AFFINITY ART 354 6PK
• 20721902333884: OXYGENATOR CB541 AFFINITY PKGNG ASSY 2PK