OXY-1 System OXY-1 PLU Disposable-US

GUDID 00860001797916

OXY-1 PLU Disposable

Breethe, Inc.

Extracorporeal membrane oxygenator Extracorporeal membrane oxygenator Extracorporeal membrane oxygenator Extracorporeal membrane oxygenator Extracorporeal membrane oxygenator Extracorporeal membrane oxygenator Extracorporeal membrane oxygenator Extracorporeal membrane oxygenator Extracorporeal membrane oxygenator Extracorporeal membrane oxygenator Extracorporeal membrane oxygenator Extracorporeal membrane oxygenator Extracorporeal membrane oxygenator Extracorporeal membrane oxygenator Extracorporeal membrane oxygenator Extracorporeal membrane oxygenator Extracorporeal membrane oxygenator Extracorporeal membrane oxygenator Extracorporeal membrane oxygenator Extracorporeal membrane oxygenator Extracorporeal membrane oxygenator Extracorporeal membrane oxygenator Extracorporeal membrane oxygenator Extracorporeal membrane oxygenator Extracorporeal membrane oxygenator Extracorporeal membrane oxygenator Extracorporeal membrane oxygenator Extracorporeal membrane oxygenator Extracorporeal membrane oxygenator Extracorporeal membrane oxygenator Extracorporeal membrane oxygenator Extracorporeal membrane oxygenator Extracorporeal membrane oxygenator Extracorporeal membrane oxygenator Extracorporeal membrane oxygenator Extracorporeal membrane oxygenator Extracorporeal membrane oxygenator Extracorporeal membrane oxygenator Extracorporeal membrane oxygenator Extracorporeal membrane oxygenator Extracorporeal membrane oxygenator Extracorporeal membrane oxygenator Extracorporeal membrane oxygenator Extracorporeal membrane oxygenator Extracorporeal membrane oxygenator

• Primary Device ID: 00860001797916
• NIH Device Record Key: 3eb109c2-b825-48b9-a544-6756eaf41ff2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OXY-1 System
• Version Model Number: OXY-1 PLU Disposable
• Catalog Number: OXY-1 PLU Disposable-US
• Company DUNS: 079455574
• Company Name: Breethe, 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: true
• Expiration Date: true
• 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	00860001797916 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200109
• Premarket Notification: K223161

FDA Product Code

• DTZ: Oxygenator, 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: 2020-12-08
• Device Publish Date: 2020-11-30

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