GUDID 20199150044515

CUSTOM PACK BB12N37R1 5PK LOWER LMB

MEDTRONIC, INC.

Cardiopulmonary bypass system blood tubing set

• Primary Device ID: 20199150044515
• NIH Device Record Key: 7e88ff2e-b279-437f-9f14-4bd59b64eb21
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: BB12N37R1
• 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	00199150044504 [Primary]
GS1	20199150044515 [Package]; Contains: 00199150044504; Package: PK [5 Units]; In Commercial Distribution

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: 2025-09-15
• Device Publish Date: 2025-09-05

Devices Manufactured by MEDTRONIC, INC.

• 00199150009114 - NA: 2025-09-15 CUSTOM PACK BB10Z98R7 PED E
• 00199150044467 - NA: 2025-09-15 CUSTOM PACK BB0F74R12 L SUPPORT
• 00199150044498 - NA: 2025-09-15 CUSTOM PACK BB12M12R5 CPB
• 20199150044515 - NA: 2025-09-15CUSTOM PACK BB12N37R1 5PK LOWER LMB
• 20199150044515 - NA: 2025-09-15 CUSTOM PACK BB12N37R1 5PK LOWER LMB
• 00199150044641 - NA: 2025-09-15 CUSTOM PACK BB12P94R2 EVL IOM SUPPO
• 00199150044658 - NA: 2025-09-15 CUSTOM PACK SSBB12R80R HLN
• 00199150044665 - NA: 2025-09-15 CUSTOM PACK BB12E50R5 HLO SPECT PUM
• 20199150045222 - NA: 2025-09-15 CUSTOM PACK 12R69R 10PK EVL