GUDID 20613994367529

CUSTOM PACK CB5D74R1 5PK CB SUCKER

MEDTRONIC, INC.

Cardiopulmonary bypass system tubing set

• Primary Device ID: 20613994367529
• NIH Device Record Key: 50fbc10e-baef-4466-91fb-2b07af83716d
• Commercial Distribution Discontinuation: 2018-10-24
• Commercial Distribution Status: Not in Commercial Distribution
• Version Model Number: CB5D74R1
• 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	00613994367525 [Primary]
GS1	20613994367529 [Package]; Contains: 00613994367525; Package: PK [5 Units]; Discontinued: 2018-10-24; Not 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: 4
• Public Version Date: 2018-12-19
• Device Publish Date: 2015-06-11

Devices Manufactured by MEDTRONIC, INC.

• 00199150050161 - NA: 2025-09-29 CUSTOM PACK HLO BB12D44R4 PUMP PK
• 00199150050178 - NA: 2025-09-29 CUSTOM PACK BB4W67R26 EVL ADULT E
• 00199150050185 - NA: 2025-09-29 CUSTOM PACK BB4Q12R27 UNIV H/L
• 20199150050202 - NA: 2025-09-29 CUSTOM PACK BB12P63R 4PK GPS TABLE PK
• 00199150050871 - NA: 2025-09-29 CUSTOM PACK BB11R66R2 TBL 1/4
• 00763000877033 - SPRINTER® LEGEND: 2025-09-29 BALLOON SPL15006X SPR LEG RX US M
• 00763000877040 - SPRINTER® LEGEND: 2025-09-29 BALLOON SPL15010X SPR LEG RX US M
• 00763000877057 - SPRINTER® LEGEND: 2025-09-29 BALLOON SPL15012X SPR LEG RX US M