GUDID 20763000168456

CANNULA KIT DLP10Q79R 5PK AFFINITY

MEDTRONIC, INC.

Cardiopulmonary bypass system tubing set

• Primary Device ID: 20763000168456
• NIH Device Record Key: a35b7243-e6f7-43d3-9a10-94b01162808c
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: DLP10Q79R
• 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
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000168445 [Primary]
GS1	20763000168456 [Package]; Contains: 00763000168445; Package: PK [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K924529

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: 2018-08-07
• Device Publish Date: 2018-07-07

Devices Manufactured by MEDTRONIC, INC.

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• 00763000997984 - NA: 2025-03-07 CUSTOM PACK BB11F56R9 PEDS V
• 00763000999346 - NA: 2025-03-07 CUSTOM PACK BB3R67R6 SU AVLOOP
• 20763000999364 - NA: 2025-03-07 CUSTOM PACK BB8A42R1 2PK TAVR PACK
• 20763000999388 - NA: 2025-03-07 CUSTOM PACK BB3J83R2 5PK 38X332X16
• 20763000999401 - NA: 2025-03-07 CUSTOM PACK BB11J01R1 5PK BRIDGE SUP
• 00763000999513 - NA: 2025-03-07 CUSTOM PACK BB11F41R3 ADLT SUPP PAC
• 20763000999777 - NA: 2025-03-07 CUSTOM PACK BB12M84R1 10PK 3/8 SUPP LINE