GUDID 00763000286583

CUSTOM PACK 8T70R2 MSS PACK

MEDTRONIC, INC.

Cardiopulmonary bypass system tubing set

• Primary Device ID: 00763000286583
• NIH Device Record Key: 766da07c-100c-43f2-b804-05945ecbd4b2
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 8T70R2
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000286583 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171308

FDA Product Code

• DWF: Catheter, cannula and tubing, vascular, cardiopulmonary bypass

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-07-09
• Device Publish Date: 2019-07-01

Devices Manufactured by MEDTRONIC, INC.

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• 00763000659202 - SimuForm™: 2026-02-09 RING 7800RR24 SIMUFORM SR 24MM MDR
• 00763000659219 - SimuForm™: 2026-02-09 RING 7800RR26 SIMUFORM SR 26MM MDR
• 00763000659226 - SimuForm™: 2026-02-09 RING 7800RR28 SIMUFORM SR 28MM MDR
• 00763000659233 - SimuForm™: 2026-02-09 RING 7800RR30 SIMUFORM SR 30MM MDR
• 00763000659240 - SimuForm™: 2026-02-09 RING 7800RR32 SIMUFORM SR 32MM MDR
• 00763000659257 - SimuForm™: 2026-02-09 RING 7800RR34 SIMUFORM SR 34MM MDR
• 00763000659264 - SimuForm™: 2026-02-09 RING 7800RR36 SIMUFORM SR 36MM MDR