GUDID 00643169047921

CUSTOM PACK CB7B00R3 VL SUPORT

MEDTRONIC, INC.

Cardiopulmonary bypass system tubing set

• Primary Device ID: 00643169047921
• NIH Device Record Key: fa6f7a1f-61ec-4ccf-8567-f5b6183e4486
• Commercial Distribution Discontinuation: 2016-03-31
• Commercial Distribution Status: Not in Commercial Distribution
• Version Model Number: CB7B00R3
• 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	00643169047921 [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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-06-11

Devices Manufactured by MEDTRONIC, INC.

• 00199150003709 - Sphere-9™ Catheter: 2026-03-02 CATHETER AFR-00001 SPHERE 9 US GAL
• 20763000558189 - CLOTtrac™: 2026-03-02 CONTROL 550-01 CLOTTRAC CWB
• 20763000558196 - CLOTtrac™: 2026-03-02 CONTROL 550-07 CLOTTRAC HR 15BX
• 20763000558202 - CLOTtrac™: 2026-03-02 CONT 550-08 CLOTTRAC HR ABN BXD ASY
• 20763000558219 - CLOTtrac™: 2026-03-02 CONT 550-09 CLOTTRAC LR ABN BXD ASY
• 20763000558226 - CLOTtrac™: 2026-03-02 CONT 550-10 CLOTTRAC RACT ABN
• 20763000558233 - CLOTtrac™: 2026-03-02 CONTROL 550-12 CLOTTRAC HTC
• 20763000558295 - RACT: 2026-03-02 CARTRIDGE 402-02 ACT RACT 17 LAN