RespondER Emergency Rescue CPR Mask with Oxygen Port in Clam Shell AMP0826

GUDID 00852696007067

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.

Allied Medical Products

Cardiopulmonary resuscitation mask, single-use

• Primary Device ID: 00852696007067
• NIH Device Record Key: 06945e21-c282-4df9-a380-5094556c697b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RespondER Emergency Rescue CPR Mask with Oxygen Port in Clam Shell
• Version Model Number: AMP0826
• Catalog Number: AMP0826
• Company DUNS: 121306984
• Company Name: Allied Medical Products
• 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: true
• Expiration Date: false
• 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: 7153582329
• Email: help@aeds.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00852696007050 [Primary]
GS1	00852696007067 [Package]; Contains: 00852696007050; Package: Case [100 Units]; In Commercial Distribution

FDA Product Code

• CBP: Valve, Non-Rebreathing

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-06-03

Devices Manufactured by Allied Medical Products

• 00852696007029 - RespondER Emergency Rescue CPR Mask with Oxygen Port: 2018-03-29 RespondER Emergency Rescue CPR Mask with Oxygen Port is a non-invasive face shield with an integral/removable non-rebreathing va
• 00852696007067 - RespondER Emergency Rescue CPR Mask with Oxygen Port in Clam Shell: 2018-03-29RespondER 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.
• 00852696007067 - RespondER Emergency Rescue CPR Mask with Oxygen Port in Clam Shell: 2018-03-29 RespondER Emergency Rescue CPR Mask with Oxygen Port is a non-invasive face shield with an integral/removable non-rebreathing va