GUDID 00199150058976

CUSTOM PACK PDBB12P71R2 HLO HEATT

MEDTRONIC, INC.

Cardiopulmonary bypass system blood tubing set

• Primary Device ID: 00199150058976
• NIH Device Record Key: 23e81618-8ee6-4ae4-81c6-6d2130184ca1
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: PDBB12P71R2
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00199150058976 [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: 2025-11-24
• Device Publish Date: 2025-11-14

Devices Manufactured by MEDTRONIC, INC.

• 00199150057177 - NA: 2025-11-24 CUSTOM PACK BB3Z71R34 HLO PRIMARY
• 00199150058976 - NA: 2025-11-24CUSTOM PACK PDBB12P71R2 HLO HEATT
• 00199150058976 - NA: 2025-11-24 CUSTOM PACK PDBB12P71R2 HLO HEATT
• 00199150060122 - NA: 2025-11-24 CUSTOM PACK BB12S52R1 EVL 3/8 PACK
• 00763000849801 - Liberant™: 2025-11-24 CONSOLE LMT-BCU LIBERANT
• 00763000913069 - InterStim™ SureScan™: 2025-11-24 LEAD 978A128 ISTM 2.16MM EUMDR EMAN LI08
• 00763000913083 - InterStim™ SureScan™: 2025-11-24 LEAD 978A133 ISTM 2.16MM EMAN EUMDR LI08
• 00763000913106 - InterStim™ SureScan™: 2025-11-24 LEAD 978A141 ISTM 2.16MM EMAN EUMDR LI08
• 00763000913120 - InterStim™ SureScan™: 2025-11-24 LEAD 978B128 ISTM 4.32MM EUMDR EMAN LI08