GUDID 00199150050161

CUSTOM PACK HLO BB12D44R4 PUMP PK

MEDTRONIC, INC.

Cardiopulmonary bypass system blood tubing set

• Primary Device ID: 00199150050161
• NIH Device Record Key: 9611b0fc-ab5a-4eca-837a-ff745036189f
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: BB12D44R4
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00199150050161 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171979

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: 2025-09-29
• Device Publish Date: 2025-09-20

Devices Manufactured by MEDTRONIC, INC.

• 00199150050161 - NA: 2025-09-29CUSTOM PACK HLO BB12D44R4 PUMP PK
• 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