GUDID 20199150068290

CUSTOM PACK 12T24R 5PK ACC CARDIO

MEDTRONIC, INC.

Cardiopulmonary bypass system blood tubing set

• Primary Device ID: 20199150068290
• NIH Device Record Key: 3df8ad23-a4a5-4dc9-8645-82aaa5fe32fc
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 12T24R
• 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	00199150068289 [Primary]
GS1	20199150068290 [Package]; Contains: 00199150068289; Package: PK [5 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: 2026-02-02
• Device Publish Date: 2026-01-24

Devices Manufactured by MEDTRONIC, INC.

• 00199150068180 - NA: 2026-02-02 CUSTOM PACK BB12H59R3 HLN UCHICAGCP
• 00199150068210 - NA: 2026-02-02 CUSTOM PACK BB8Y34R13 LOWVOLPED
• 20199150068238 - NA: 2026-02-02 CUSTOM PACK BB12S73R1 20PK ACC 3LF
• 20199150068290 - NA: 2026-02-02CUSTOM PACK 12T24R 5PK ACC CARDIO
• 20199150068290 - NA: 2026-02-02 CUSTOM PACK 12T24R 5PK ACC CARDIO
• 20199150068405 - NA: 2026-02-02 CUSTOM PACK BB12R56R3 4PK CPN DEL NI
• 00199150061679 - NA: 2026-01-29 CUSTOM PACK BB12S73R HLN 3LF
• 20613994654063 - DLP®: 2026-01-29 PCP SET 50011 5FR - 14GA 10PK 17L
• 00199150027521 - Cardioblate™: 2026-01-26 CLAMP 49321 CARDIOBLATE BP2 FT