Rescue Breather 01PV1503W-CS

GUDID 17540195056517

Rescue Breather® CPR Pocket Ventilator provides the rescuer with a safe and effective means to perform life saving expired air resuscitation while offering maximum protection from the potential risks of disease transfer for both the patient and the rescuer.The Rescue Breather® CPR Pocket Ventilator comes standard with a disposable Low-Resistance Clear One-Way-Valve with built-in 3M Filtrete® Filter, protected Oxygen inlet, adjustable Head Strap, pair of “Latex Free” Nitrile Gloves, Instructions leaflet and Clam Shell Carrying Case.

O-Two Medical Technologies Inc

Cardiopulmonary resuscitation mask, single-use

• Primary Device ID: 17540195056517
• NIH Device Record Key: d01d082d-793c-4032-9a4e-12c1b4532edb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rescue Breather
• Version Model Number: 01PV1503W
• Catalog Number: 01PV1503W-CS
• Company DUNS: 206449154
• Company Name: O-Two Medical Technologies Inc
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

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

Operating and Storage Conditions

• Storage Environment Temperature: Between -60 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07540195056510 [Primary]
GS1	17540195056517 [Package]; Contains: 07540195056510; Package: [12 Units]; In Commercial Distribution

FDA Product Code

• KGB: Mask, Oxygen, Non-Rebreathing

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: 2019-05-10
• Device Publish Date: 2019-05-02

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