GUDID 00763000011567

CUSTOM PACK HY3P08R22 ADLT PER

MEDTRONIC, INC.

Cardiopulmonary bypass system tubing set

• Primary Device ID: 00763000011567
• NIH Device Record Key: dbf70bbb-8777-4af7-9561-dd2037ca1273
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: HY3P08R22
• 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: 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
• 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	00763000011567 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K800178

FDA Product Code

• DWE: TUBING, PUMP, 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: 2017-06-26

Devices Manufactured by MEDTRONIC, INC.

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• 00199150027538 - Cardioblate™: 2026-01-26 CLAMP 49341 CARDIOBLATE LP FT
• 00199150027569 - Cardioblate™: 2026-01-26 CARDIOBLATE 60831 BP2 DEVICE EN
• 00199150027576 - Cardioblate®: 2026-01-26 CARDIOBLATE 60841 LP STANDALONE EN
• 00763000999414 - SYNCHROMED™ III: 2026-01-23 PUMP 8667-20 SYNCHROMEDIII EMAN
• 00763000999421 - SYNCHROMED™ III: 2026-01-23 PUMP 8667-40 SYNCHROMEDIII EMAN
• 10681490185162 - NA: 2026-01-21 POUCH 8590-1 SYNCHROMED PUMP US
• 00763000300623 - N/A: 2026-01-08 COMM HANDSET KIT TH90T01 TDD PROX MYPTM