RespondER Emergency Rescue CPR Mask with Oxygen Port

Basic Information

• Brand Name: RespondER Emergency Rescue CPR Mask with Oxygen Port
• Primary DI: 00852696007012
• Version / Model: AMP0825
• Catalog Number: AMP0825
• Company Name: Allied Medical Products
• Labeler DUNS: 121306984
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-06-03
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 420c5e2e-23f8-4f29-bbff-13c2af15c6d5

Device Description

RespondER Emergency Rescue CPR Mask with Oxygen Port is a non-invasive face shield with an integral/removable non-rebreathing valve which serves as a physical barrier for rescuers providing immediate life support to health emergency victims requiring oxygen support or cardiopulmonary resuscitation (CPR) rescue techniques.

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: Yes
• 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: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
CBP	Valve, Non-Rebreathing	Anesthesiology	868.5870	2

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	00852696007029	GS1	Case	150	In Commercial Distribution
Primary	00852696007012	GS1

Customer Contacts

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