GUDID 30613994010446

RESERVOIR 61399401044 1EA BLADDER R38

MEDTRONIC, INC.

Cardiotomy reservoir

• Primary Device ID: 30613994010446
• NIH Device Record Key: e7298398-6985-48aa-9bc5-3b5f8ad5eab7
• Commercial Distribution Discontinuation: 2018-07-23
• Commercial Distribution Status: Not in Commercial Distribution
• Version Model Number: 61399401044
• 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

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	30613994010446 [Primary]
GS1	50613994010440 [Package]; Package: PK [5 Units]; Discontinued: 2018-07-23; Not in Commercial Distribution
GS1	70613994010444 [Package]; Contains: 50613994010440; Package: CT [4 Units]; Discontinued: 2018-07-23; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K882720

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: 5
• Public Version Date: 2020-01-22
• Device Publish Date: 2017-05-06

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