GUDID 00199150071883

CUSTOM PACK BB12T77R1 HLO ADLT TUBI

MEDTRONIC, INC.

Cardiopulmonary bypass system blood tubing set

• Primary Device ID: 00199150071883
• NIH Device Record Key: a83ca15b-277a-44bf-8c57-af9ae9e60953
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: BB12T77R1
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00199150071883 [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: 2026-03-09
• Device Publish Date: 2026-03-01

Devices Manufactured by MEDTRONIC, INC.

• 00199150071883 - NA: 2026-03-09CUSTOM PACK BB12T77R1 HLO ADLT TUBI
• 00199150071883 - NA: 2026-03-09 CUSTOM PACK BB12T77R1 HLO ADLT TUBI
• 00763000936594 - Concerto Versa™: 2026-03-09 COIL CONCERTO VERSA CV-3-5
• 00763000936600 - Concerto Versa™: 2026-03-09 COIL CONCERTO VERSA CV-3-15
• 00763000936617 - Concerto Versa™: 2026-03-09 COIL CONCERTO VERSA CV-4-5 US
• 00763000936624 - Concerto Versa™: 2026-03-09 COIL CONCERTO VERSA CV-4-15
• 00763000936631 - Concerto Versa™: 2026-03-09 COIL CONCERTO VERSA CV-5-20
• 00763000936648 - Concerto Versa™: 2026-03-09 COIL CONCERTO VERSA CV-5-30
• 00763000936655 - Concerto Versa™: 2026-03-09 COIL CONCERTO VERSA CV-6-20