GUDID 00199150007172

CUSTOM PACK PDBB11V44R10 CORE PIX

MEDTRONIC, INC.

Cardiopulmonary bypass system blood tubing set

• Primary Device ID: 00199150007172
• NIH Device Record Key: a1d77de9-5f08-4d0d-89d4-6281e180e584
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: PDBB11V44R10
• 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
• 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
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00199150007172 [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: 2025-04-21
• Device Publish Date: 2025-04-13

Devices Manufactured by MEDTRONIC, INC.

• 00199150007172 - NA: 2025-04-21CUSTOM PACK PDBB11V44R10 CORE PIX
• 00199150007172 - NA: 2025-04-21 CUSTOM PACK PDBB11V44R10 CORE PIX
• 00199150007547 - NA: 2025-04-21 CUSTOM PACK SSBB10Z49R20 NEW CONFIG
• 00763000812041 - NA: 2025-04-21 CAP 5867-3M STERILE MDR
• 00763000812058 - NA: 2025-04-21 SERVICE KIT 5873C LEAD MDR
• 00763000947064 - Bio-Medicus™: 2025-04-21 CANNULA 96530-115 BIO-MEDICUS 15FR
• 00763000947071 - Bio-Medicus™: 2025-04-21 CANNULA 96530-117 BIO-MEDICUS 17FR
• 00763000947088 - Bio-Medicus™: 2025-04-21 CANNULA 96530-119 BIO-MEDICUS 19FR
• 00763000947095 - Bio-Medicus™: 2025-04-21 CANNULA 96530-121 BIO-MEDICUS 21FR