GUDID 00199150009220

CUSTOM PACK BB9L80R8 SADT FUS

MEDTRONIC, INC.

Cardiopulmonary bypass system blood tubing set

• Primary Device ID: 00199150009220
• NIH Device Record Key: f4d5d36d-63d0-4032-a533-8909020af4e6
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: BB9L80R8
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00199150009220 [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: 2025-05-05
• Device Publish Date: 2025-04-27

Devices Manufactured by MEDTRONIC, INC.

• 00199150009220 - NA: 2025-05-05CUSTOM PACK BB9L80R8 SADT FUS
• 00199150009220 - NA: 2025-05-05 CUSTOM PACK BB9L80R8 SADT FUS
• 00199150014248 - NA: 2025-05-05 CUSTOM PACK BB0L44R32 OPEN H
• 00199150015290 - NA: 2025-05-05 CUSTOM PACK BB10G30R4 TABLE
• 20199150001303 - NA: 2025-04-29 CUSTOM PACK BB12M54R2 10PK 1/4 LINE
• 20199150003758 - NA: 2025-04-28 CUSTOM PACK BB12F63R1 5PK 1/4 BRIDGE
• 20199150003956 - NA: 2025-04-28 CUSTOM PACK BB11D74R1 10PK ACCESSORY PK
• 00199150003983 - NA: 2025-04-28 CUSTOM PACK BB8A17R3 PEDS E PK
• 20199150004007 - NA: 2025-04-28 CUSTOM PACK BB11X47R1 10PK UTMC PIGTAILS