GUDID 20885074165848

CUSTOM PACK CB3U56R1 2PK WILKESBRRE RHS

MEDTRONIC, INC.

Cardiopulmonary bypass system tubing set Cardiopulmonary bypass system blood tubing set Cardiopulmonary bypass system blood tubing set Cardiopulmonary bypass system blood tubing set Cardiopulmonary bypass system blood tubing set Cardiopulmonary bypass system blood tubing set Cardiopulmonary bypass system blood tubing set Cardiopulmonary bypass system blood tubing set Cardiopulmonary bypass system blood tubing set

• Primary Device ID: 20885074165848
• NIH Device Record Key: c9456d96-21b4-45e5-85e5-f55eca0a3c1c
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: CB3U56R1
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00885074165844 [Primary]
GS1	20885074165848 [Package]; Contains: 00885074165844; Package: PK [2 Units]; In Commercial Distribution

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-06-12

Devices Manufactured by MEDTRONIC, INC.

• 00763000957544 - NA: 2024-06-28 CUSTOM PACK BB7J30R4 LIV SHUNT
• 00763000957551 - NA: 2024-06-28 CUSTOM PACK BBB7S09R13 SUPPRT SM
• 20763000957760 - NA: 2024-06-28 CUSTOM PACK BB12G13R 5PK FL MEM MANIFOL
• 00763000957780 - NA: 2024-06-28 CUSTOM PACK 11H88R7 ACCESSORY PACK
• 00763000958015 - NA: 2024-06-28 CUSTOM PACK HY11R06R2 SUPP 1/4 PK
• 20763000958033 - NA: 2024-06-28 CUSTOM PACK BB9B82R2 5PK JUMP PACK
• 00763000958695 - NA: 2024-06-28 CUSTOM PACK BB11F32R5 ACCESSORY 1/4
• 00763000958701 - NA: 2024-06-28 CUSTOM PACK BB12F79R2 NT PK