GUDID 20199150025408

CUSTOM PACK BB11M89R1 4PK 3/8E

MEDTRONIC, INC.

Cardiopulmonary bypass system blood tubing set

• Primary Device ID: 20199150025408
• NIH Device Record Key: 4166953b-b92b-4057-a859-749a0437b3f1
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: BB11M89R1
• 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
• 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
• 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	00199150025398 [Primary]
GS1	20199150025408 [Package]; Contains: 00199150025398; Package: PK [4 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: 2025-06-20
• Device Publish Date: 2025-06-12

Devices Manufactured by MEDTRONIC, INC.

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• 20199150024364 - NA: 2025-06-20 CUSTOM PACK BB9Q89R2 10PK 10PK 1/4
• 00199150024377 - NA: 2025-06-20 CUSTOM PACK BB10J06R16 3/8 E C L S
• 20199150024418 - NA: 2025-06-20 CUSTOM PACK BB11M93R1 4PK 1/4 E
• 20199150025378 - NA: 2025-06-20 CUSTOM PACK BB12A48R2 5PK Y PIGTAILS
• 20199150025408 - NA: 2025-06-20CUSTOM PACK BB11M89R1 4PK 3/8E
• 20199150025408 - NA: 2025-06-20 CUSTOM PACK BB11M89R1 4PK 3/8E
• 00199150025855 - NA: 2025-06-20 CUSTOM PACK BB6T48R18 PEDS V
• 00199150025862 - NA: 2025-06-20 CUSTOM PACK BB12C61R2 TBL W PMPHEAD