GUDID 20613994842903

RESERVOIR EL2120 4 LITER 120 MICRON 6PK

MEDTRONIC, INC.

Cardiotomy reservoir Cardiotomy reservoir

• Primary Device ID: 20613994842903
• NIH Device Record Key: 56103033-1219-4d53-b4b1-9dd0d7d46c8c
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: EL2120
• 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: 120 Micrometer
• Pore Size: 120 Micrometer

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	00613994842909 [Primary]
GS1	20613994842903 [Package]; Contains: 00613994842909; Package: PK [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K930154

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: 2016-06-16

Devices Manufactured by MEDTRONIC, INC.

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• 00763000959838 - NA: 2024-07-05 CUSTOM PACK BB11Q22R7 LOURDES SUP P
• 00763000959845 - NA: 2024-07-05 CUSTOM PACK 12G61R1 NURSES