OXY-1 System 001-3300-039

GUDID 00860001797961

Console Intake Filter, 5pk

Breethe, Inc.

Cardiopulmonary bypass system, non-roller type

• Primary Device ID: 00860001797961
• NIH Device Record Key: 1f11066a-8e43-450f-a753-4d7aa1b042b8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OXY-1 System
• Version Model Number: Console Intake Filter, 5pk
• Catalog Number: 001-3300-039
• Company DUNS: 079455574
• Company Name: Breethe, Inc.
• Device Count: 5
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860001797961 [Unit of Use]
GS1	10860001797968 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200109

FDA Product Code

• DWA: Control, Pump Speed, Cardiopulmonary Bypass

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-12-10
• Device Publish Date: 2020-12-02

On-Brand Devices [OXY-1 System]

• 00860001797954: OXY-1 E-drive
• 00860001797947: OXY-1 Pump Driver
• 00860001797930: OXY-1-Console
• 00860001797916: OXY-1 PLU Disposable
• 00860001797909: OXY-1 System
• 00860001797961: Console Intake Filter, 5pk
• 10860001797920: OXY-1 Condensate Tray