Rescue Breather 01RB1000

GUDID 07540195055018

The Rescue Breather consists of a one-way valve that has a large block is placed in a patient's mouth, The person providing CPR then blows through the valve to inflate patient's lung. The intended purpose of the valve and the filter is to prevent any cross contamination and potential cross infection by preventing contact with body fluids such as vomit, blood or saliva between patient and first aid provider.

O-Two Medical Technologies Inc

Face splash shield, single-use

• Primary Device ID: 07540195055018
• NIH Device Record Key: 9d3dc24c-ddaa-474b-8f01-8db7f1f095cb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rescue Breather
• Version Model Number: 01RB1000U
• Catalog Number: 01RB1000
• Company DUNS: 206449154
• Company Name: O-Two Medical Technologies 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-800-387-3405
• Email: cs@otwo.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07540195055018 [Primary]
GS1	17540195055015 [Package]; Package: Packaging box [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K940927

FDA Product Code

• LYM: Device, Cpr Assist

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-04-06
• Device Publish Date: 2016-09-23

On-Brand Devices [Rescue Breather]

• 07540195055018: The Rescue Breather consists of a one-way valve that has a large block is placed in a patient's
• 17540195056517: Rescue Breather® CPR Pocket Ventilator provides the rescuer with a safe and effective means to
• 17540195056500: Rescue Breather® CPR Pocket Ventilator provides the rescuer with a safe and effective means to