GUDID 00199150045839

CUSTOM PACK BB12J21R6 EVL ADULT EC

MEDTRONIC, INC.

Cardiopulmonary bypass system blood tubing set

• Primary Device ID: 00199150045839
• NIH Device Record Key: 9312cf83-822a-4a24-b339-cce7d8d82182
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: BB12J21R6
• 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
• 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
• 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	00199150045839 [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: 2025-09-22
• Device Publish Date: 2025-09-12

Devices Manufactured by MEDTRONIC, INC.

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• 00199150045693 - NA: 2025-09-22 CUSTOM PACK BB12R38R EVL 1/4ECC
• 00199150045808 - NA: 2025-09-22 CUSTOM PACK BB12F62R4 HLO UOF HE PA
• 00199150045815 - NA: 2025-09-22 CUSTOM PACK BB10B09R2 EVL EC SUP PK
• 00199150045822 - NA: 2025-09-22 CUSTOM PACK BB2S09R29 CV PACK
• 00199150045839 - NA: 2025-09-22CUSTOM PACK BB12J21R6 EVL ADULT EC
• 00199150045839 - NA: 2025-09-22 CUSTOM PACK BB12J21R6 EVL ADULT EC
• 00199150045860 - NA: 2025-09-22 CUSTOM PACK BB10B53R7 ADULT SUPPORT
• 00199150046010 - NA: 2025-09-22 CUSTOM PACK BB5G56R17 PUMP TBL