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Re: vlscout post# 1724

Thursday, 10/20/2011 9:48:17 AM

Thursday, October 20, 2011 9:48:17 AM

Post# of 2463
I don't think this is true either:

"You still don't get it. The needle sets do not replace the tubing sets, they will replace other manufacturers' needle sets. These are TWO different products."

They refer to the High-Flo has the "new needle set" -- it can be used with the Freedom60 and is expected to be used with the Freedom60. From an older filing:

"We have been developing our own needle administration sets for subcutaneous immune globulin, called the Daisy Set which incorporates many enhanced features that we believe will address many of the issues faced by current offerings. The current devices are available with a number of needles from one to six, in three different lengths, and in some cases two different diameters, thus creating a logistical problem for providers to store 38 different kinds of needle sets. Our new Daisy needle sets contain an adjustable needle depth setting, and have the ability to connect to each other to create any number of joined needles, thus reducing all the offerings from 38 to only one type of needle set. In addition, since we have pioneered the fluidics for these administrations, we have designed the Daisy set for very rapid administrations with improved safety. An FDA 510(k) has been submitted for the new set and updated performance features of the Freedom60."

Raw

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