GUDID 00199150062027

CUSTOM PACK BB12R85R AVL 3/8 ECCPK

MEDTRONIC, INC.

Cardiopulmonary bypass system blood tubing set

• Primary Device ID: 00199150062027
• NIH Device Record Key: 9c276d52-f540-4044-b06a-0743e1308a39
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: BB12R85R
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00199150062027 [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: 2025-12-08
• Device Publish Date: 2025-11-30

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• 00199150062027 - NA: 2025-12-08CUSTOM PACK BB12R85R AVL 3/8 ECCPK
• 00199150062027 - NA: 2025-12-08 CUSTOM PACK BB12R85R AVL 3/8 ECCPK
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• 00643169265691 - NA: 2025-12-08 LEAD ACC KIT 6056M GLOBAL 17L NEW ACI
• 00199150060467 - NA: 2025-11-28 CUSTOM PACK BB11Q49R14 EVL 3/8 EC
• 00199150060627 - NA: 2025-11-28 CUSTOM PACK BB12M28R9 HLO QHLM-FROS