OXY-1 System 001-0301-001

GUDID 00860001797947

OXY-1 Pump Driver

Breethe, Inc.

Cardiopulmonary bypass system, non-roller type Cardiopulmonary bypass system, non-roller type Cardiopulmonary bypass system, non-roller type Cardiopulmonary bypass system, non-roller type Cardiopulmonary bypass system, non-roller type Cardiopulmonary bypass system, non-roller type Cardiopulmonary bypass system, non-roller type Cardiopulmonary bypass system, non-roller type Cardiopulmonary bypass system, non-roller type Cardiopulmonary bypass system, non-roller type Cardiopulmonary bypass system, non-roller type Cardiopulmonary bypass system, non-roller type Cardiopulmonary bypass system, non-roller type Cardiopulmonary bypass system, non-roller type Cardiopulmonary bypass system, non-roller type Cardiopulmonary bypass system, non-roller type Cardiopulmonary bypass system, non-roller type Cardiopulmonary bypass system, non-roller type Cardiopulmonary bypass system, non-roller type Cardiopulmonary bypass system, non-roller type Cardiopulmonary bypass system, non-roller type Cardiopulmonary bypass system, non-roller type Cardiopulmonary bypass system, non-roller type Cardiopulmonary bypass system, non-roller type Cardiopulmonary bypass system, non-roller type Cardiopulmonary bypass system, non-roller type Cardiopulmonary bypass system, non-roller type Cardiopulmonary bypass system, non-roller type Cardiopulmonary bypass system, non-roller type

• Primary Device ID: 00860001797947
• NIH Device Record Key: fa5e2ab5-b104-44e2-9fe3-543b31066ee5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OXY-1 System
• Version Model Number: OXY-1 Pump Driver
• Catalog Number: 001-0301-001
• 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• 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	00860001797947 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200109
• Premarket Notification: K223161

FDA Product Code

• DTZ: Oxygenator, Cardiopulmonary Bypass
• KFM: Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type

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: 2020-12-08
• 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