GUDID 00643169998865

CUSTOM PACK 9Q76R PED 3/8

MEDTRONIC, INC.

Cardiopulmonary bypass system tubing set

• Primary Device ID: 00643169998865
• NIH Device Record Key: 510623a9-ad85-4e03-a3ef-9c56e5e36476
• Commercial Distribution Discontinuation: 2018-10-24
• Commercial Distribution Status: Not in Commercial Distribution
• Version Model Number: 9Q76R
• 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 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
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169998865 [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: 4
• Public Version Date: 2019-01-04
• Device Publish Date: 2017-04-06

Devices Manufactured by MEDTRONIC, INC.

• 00199150006434 - NA: 2025-04-22 CUSTOM PACK BB11P23R4 LARGO DUAL V
• 00199150006465 - NA: 2025-04-22 CUSTOM PACK BB12E01R8 MAINPCK
• 00199150006618 - NA: 2025-04-22 CUSTOM PACK BB6N93R9 OSF ADPTR
• 00199150006861 - NA: 2025-04-22 CUSTOM PACK BB6Y28R11 CMAG L I V
• 00199150006878 - NA: 2025-04-22 CUSTOM PACK BB6Y37R3 CP PRIME
• 20199150006896 - NA: 2025-04-22 CUSTOM PACK BB10Y97R1 5PK MANIFOLD
• 20199150006919 - NA: 2025-04-22 CUSTOM PACK BB10Y99R1 10PK ARTERIAL Y
• 00199150006922 - NA: 2025-04-22 CUSTOM PACK BB11Q27R2 MANIFOLD