GUDID 00199150042098

CUSTOM PACK BB8B09R20 HLN OR INFANT

MEDTRONIC, INC.

Cardiopulmonary bypass system blood tubing set

• Primary Device ID: 00199150042098
• NIH Device Record Key: a3f2efbc-3ed1-4ae1-94ba-fcd934f924f0
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: BB8B09R20
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00199150042098 [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: 2025-09-08
• Device Publish Date: 2025-08-29

Devices Manufactured by MEDTRONIC, INC.

• 00199150042098 - NA: 2025-09-08CUSTOM PACK BB8B09R20 HLN OR INFANT
• 00199150042098 - NA: 2025-09-08 CUSTOM PACK BB8B09R20 HLN OR INFANT
• 00199150042661 - NA: 2025-09-08 CUSTOM PACK BB0C01R32 EVL 1/4 SUPPT
• 00199150042753 - NA: 2025-09-08 CUSTOM PACK BB9F06R5 EVL WCH NEONA
• 00199150043392 - NA: 2025-09-08 CUSTOM PACK BB12D74R5 HLO ALLIDON
• 00199150043507 - NA: 2025-09-08 CUSTOM PACK BB12Q89R1 EVL 3/8
• 00199150043538 - NA: 2025-09-08 CUSTOM PACK BB12Q60R1 HLO ST BERNAR
• 00199150044436 - NA: 2025-09-08 CUSTOM PACK BB9R01R23 HLN OR PEDIA
• 20199150044454 - NA: 2025-09-08 CUSTOM PACK BB12R78R 5PK ACC PDEVL