GUDID 20199150038910

CUSTOM PACK BB5S68R5 2PK RIDEOUT

MEDTRONIC, INC.

Cardiopulmonary bypass system blood tubing set

• Primary Device ID: 20199150038910
• NIH Device Record Key: 46585299-d4ed-43ed-9085-a2cccbe38e31
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: BB5S68R5
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00199150038909 [Primary]
GS1	20199150038910 [Package]; Contains: 00199150038909; Package: PK [2 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: 2025-08-11
• Device Publish Date: 2025-08-02

Devices Manufactured by MEDTRONIC, INC.

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• 20199150038781 - NA: 2025-08-11 CUSTOM PACK BB6J25R1 10PK 3/8 TUB
• 20199150038910 - NA: 2025-08-11CUSTOM PACK BB5S68R5 2PK RIDEOUT
• 20199150038910 - NA: 2025-08-11 CUSTOM PACK BB5S68R5 2PK RIDEOUT
• 00199150038947 - NA: 2025-08-11 CUSTOM PACK BB5P55R5 ADULT VAS
• 20199150039238 - NA: 2025-08-11 CUSTOM PACK BB12R35R 20PK ACC CON1/2X3/8
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