Rescue Breather

Basic Information

• Brand Name: Rescue Breather
• Primary DI: 07540195056503
• Version / Model: 01PV1500W
• Catalog Number: 01PV1500W-CS
• Company Name: O-Two Medical Technologies Inc
• Labeler DUNS: 206449154
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-05-02
• Public Version: 1
• Public Version Date: 2019-05-10
• Public Version Status: New
• Public Device Record Key: 1b7a720e-5499-46d1-8af5-f7866885b5b5

Device Description

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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KGB	Mask, Oxygen, Non-Rebreathing	Anesthesiology	868.5570	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61326	Cardiopulmonary resuscitation mask, single-use	A flexible, form-shaped device that is placed over a patient's mouth to administer "mouth-to-mask" exhaled air from the user to the patient during cardiopulmonary resuscitation (CPR). The device is designed to replace "mouth-to-mouth" resuscitation therefore reducing the risk of cross-contamination; it is also used on manikins by students during CPR training. The device typically consists of the mask with a mouthpiece and a non-rebreathing valve and/or bacteria filter. Also referred to as a pocket face mask, it is typically used by emergency medical services (EMS) or as part of first aid kits. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	17540195056500	GS1		12	In Commercial Distribution
Primary	07540195056503	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -60 – 40 Degrees Celsius