GUDID 20673978523587

RESERVOIR EL402 4L 20MICR CARDIOTOMY 6CA

MEDTRONIC, INC.

Cardiotomy reservoir

• Primary Device ID: 20673978523587
• NIH Device Record Key: 2be5fe46-4489-4bd5-b857-9bda744cc4ac
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: EL402
• 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: false
• 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: false
• 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

Device Dimensions

• Pore Size: 20 Micrometer
• Pore Size: 20 Micrometer

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place away from extremes of temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place away from extremes of temperature.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00673978523583 [Primary]
GS1	20673978523587 [Package]; Contains: 00673978523583; Package: CT [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K926250

FDA Product Code

• DTN: RESERVOIR, BLOOD, CARDIOPULMONARY BYPASS

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-01-22
• Device Publish Date: 2016-06-24

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