Abiomed Breethe OXY-1 System 001-0403-008

GUDID 00860001797985

OXY-1 US Power Cord 3M Qty 1

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

• Primary Device ID: 00860001797985
• NIH Device Record Key: d99318d8-720c-4983-a06d-a810858663d1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Abiomed Breethe OXY-1 System
• Version Model Number: 001-0403-008
• Catalog Number: 001-0403-008
• 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: 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	00860001797985 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K223161

FDA Product Code

• DTZ: Oxygenator, 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: 2023-06-05
• Device Publish Date: 2023-05-26

On-Brand Devices [Abiomed Breethe OXY-1 System]

• 00860001797985: OXY-1 US Power Cord 3M Qty 1
• 00813502012361: OXY-1 Console Intake Filter Qty 5
• 00813502012354: OXY-1 Condensate Tray Qty 5
• 00813502013245: Tubing, Translucent Green, 1/4" x 3/8"
• 00813502013184: TUBING INSULATOR KIT