GUDID 00643169744417

CUSTOM PACK CB9E46R2 1/4 PRIME

MEDTRONIC, INC.

Cardiopulmonary bypass system tubing set

• Primary Device ID: 00643169744417
• NIH Device Record Key: a73faaca-7436-4e74-a5e3-2fcfa8c12e85
• Commercial Distribution Discontinuation: 2018-10-24
• Commercial Distribution Status: Not in Commercial Distribution
• Version Model Number: CB9E46R2
• 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: true
• Device Combination Product: true
• 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
• 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 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169744417 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K891687

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: 2019-01-04
• Device Publish Date: 2016-04-11

Devices Manufactured by MEDTRONIC, INC.

• 20199150023800 - NA: 2025-06-09 CUSTOM PACK BB11X70R1 5PK AV LOOP
• 20199150023824 - NA: 2025-06-09 CUSTOM PACK BB8A44R4 4PK HBC MYO
• 20199150024135 - NA: 2025-06-09 CUSTOM PACK BB11A07R2 5PK BRIDGE LINE
• 00613994163523 - Duran AnCore: 2025-06-09 TOOL 7620HXL HANDLE DURAN ANCORE 14L
• 00613994959546 - Open Pivot™: 2025-06-09 ACCY 558 ACTUATOR PACKAGE AVG
• 00643169402539 - MOSAIC ULTRA™: 2025-06-09 SIZERS 7308U MOSAIC ULTRA AORTIC 26L
• 00643169402591 - MOSAIC™CINCH™: 2025-06-09 SIZERS 7308C MOSAIC CINCH AORTIC 26L
• 00643169525511 - CG Future™: 2025-06-09 SIZER SET 7638S CG FUTURE 26L