GUDID 20199150041118

CUSTOM PACK BB12E30R1 10PK ACC BRIDGE

MEDTRONIC, INC.

Cardiopulmonary bypass system blood tubing set

• Primary Device ID: 20199150041118
• NIH Device Record Key: 711c5508-21fa-456c-8b7d-1ac5da60a2b1
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: BB12E30R1
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00199150041107 [Primary]
GS1	20199150041118 [Package]; Contains: 00199150041107; Package: PK [10 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: 2025-08-18
• Device Publish Date: 2025-08-08

Devices Manufactured by MEDTRONIC, INC.

• 20199150041118 - NA: 2025-08-18CUSTOM PACK BB12E30R1 10PK ACC BRIDGE
• 20199150041118 - NA: 2025-08-18 CUSTOM PACK BB12E30R1 10PK ACC BRIDGE
• 20199150041132 - NA: 2025-08-18 CUSTOM PACK BB5G89R2 2PK T SPRT
• 00763000876982 - SPRINTER® LEGEND: 2025-08-18 BALLOON SPL12506X SPR LEG RX US M
• 00763000876999 - SPRINTER® LEGEND: 2025-08-18 BALLOON SPL12510X SPR LEG RX US M
• 00763000877002 - SPRINTER® LEGEND: 2025-08-18 BALLOON SPL12512X SPR LEG RX US M
• 00763000877019 - SPRINTER® LEGEND: 2025-08-18 BALLOON SPL12515X SPR LEG RX US M
• 00763000877026 - SPRINTER® LEGEND: 2025-08-18 BALLOON SPL12520X SPR LEG RX US M
• 00763000925079 - FlexCath Cross™ Transseptal Solution: 2025-08-18 NDL 900300 FLEXCATH CROSS AG 61CM EIFU