GUDID 20763000999449

CUSTOM PACK BB6R53R1 20PK 3/8 C/WLL

MEDTRONIC, INC.

Cardiopulmonary bypass system blood tubing set

• Primary Device ID: 20763000999449
• NIH Device Record Key: b13e2904-8a3d-4c91-a6eb-2053131944d9
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: BB6R53R1
• 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	00763000999438 [Primary]
GS1	20763000999449 [Package]; Contains: 00763000999438; Package: PK [20 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: 2025-03-04
• Device Publish Date: 2025-02-24

Devices Manufactured by MEDTRONIC, INC.

• 20199150000030 - NA: 2025-03-04 CUSTOM PACK BB6Q05R1 5PK 3/8 TUB
• 20763000999449 - NA: 2025-03-04CUSTOM PACK BB6R53R1 20PK 3/8 C/WLL
• 20763000999449 - NA: 2025-03-04 CUSTOM PACK BB6R53R1 20PK 3/8 C/WLL
• 20763000999463 - NA: 2025-03-04 CUSTOM PACK BB2T40R3 2PK TABLE LINE
• 00763000999476 - NA: 2025-03-04 CUSTOM PACK BB12G75R2 WM ACC
• 20763000999494 - NA: 2025-03-04 CUSTOM PACK BB8Q15R1 10PK 1/2 VENOUS
• 00763000999506 - NA: 2025-03-04 CUSTOM PACK BB10R64R13 CAMC PERF
• 00763000582890 - Avalus™ 7400S: 2025-03-03 SIZERS 7400S AVALUS CEM GLOBAL
• 00763000582906 - Valve Handle 7420: 2025-03-03 HANDLE 7420 VLV HNDLE 234MM CEM GLOBAL