CPAP Masks, Humidifiers Classified As Class II Medical Devic

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Slinky
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CPAP Masks, Humidifiers Classified As Class II Medical Devic

Post by Slinky » Fri Oct 02, 2009 7:42 pm

Recent changes in prescription requirements from the Food and Drug Administration (FDA) classify CPAP/Bi-PAP masks and humidifiers as Class II Medical Devices.

Does anyone know what the previous classification was for them? Will this have any effect on easing or making more difficult buying equipment online? Or is this just the change in policy Johnny Goodman and cpap.com recently made us aware of?

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6PtStar
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Re: CPAP Masks, Humidifiers Classified As Class II Medical Devic

Post by 6PtStar » Fri Oct 02, 2009 7:58 pm

Slinky, I think this change is what caused Johnny to change cpap.com's selling policy. I am still waiting to see how this effects cpapauction. Under current cpap.com rules while it may effect some for the most part it is still loose enough it won't impact my buying very much because I still have an old script that is written loose enough to work for anything I need.

Best I remember masks, humidifiers did not have a classification. Only the flow generators.

Jerry

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Slinky
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Re: CPAP Masks, Humidifiers Classified As Class II Medical Devic

Post by Slinky » Fri Oct 02, 2009 8:13 pm

Thanks, Jerry. That is what I expected but .... just thought I would ask.

_________________
Mask: Quattro™ FX Full Face CPAP Mask with Headgear
Additional Comments: PR SystemOne BPAP Auto w/Bi-Flex & Humidifier - EncorePro 2.2 Software - Contec CMS-50D+ Oximeter - Respironics EverFlo Q Concentrator
Women are Angels. And when someone breaks our wings, we simply continue to fly.....on a broomstick. We are flexible like that.
My computer says I need to upgrade my brain to be compatible with its new software.