Allied Medical Products

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Valve, Non-Rebreathing (CBP) (2)

Premarket Exempt

Yes

Clear

RespondER Emergency Rescue CPR Mask with Oxygen Port - 00852696007012 Catalog Number : AMP0825

Device Description : RespondER Emergency Rescue CPR Mask with Oxygen Port is a non-invasive face shie 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 Class : 2

Duns Number: 121306984

Premarket Exempt : Yes

Product Code : CBP

Prescription Use : Yes

Device Count : 1

RespondER Emergency Rescue CPR Mask with Oxygen Port in Clam Shell - 00852696007050 Catalog Number : AMP0826