Blood and plasma processing company FreMon Scientific said on Monday that its ZipThaw, for frozen plasma thawing, has passed US FDA clearance as a Class II medical device.
According to the company, ZipThaw, used with the ZipSleeve anti-contaminant disposable barrier, is the world's first dry and portable precision plasma thawing system. Clinicians can now deliver vital plasma to patients at the right time and temperature.
In conjunction, the company's ZipThaw and ZipSleeve have earned CE Mark, ISO certification, UL Listing and now FDA clearance for thawing fresh frozen plasma (FFP) and plasma frozen within 24 hours after phlebotomy (FP24).
The company said it has designed the next generation thawing device ZipThaw that is proven to preserve coagulation factors needed in life saving transfusion procedures. ZipThaw requires nearly no maintenance, thawing is precisely measured and the end-to-end thawing process is easier to manage with fewer technical staff.
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