imugard - IMUGARD WB PLT Platelet Pooling Set seulrene Original Submission Traditional 510k Submission 5 510K SUMMARY In accordance with 21 CFR 80787h and 21 CFR 80792 the 510k Summary is provided Terumo Blood and Cell Technologies IMUGARD Platelet BioSpace IMUGARD III is a leukocyte removal filter system made from biocompatible polyurethane material Highly porous this material provides stable filtration of leukocytes and microaggregates Within the filter patented technology ensures optimal pore size distribution and pore density Entrapment of leukocytes is achieved mainly by pore size IMUGARD enables extended shelf life of platelets from the standard five days to seven days 1 This can help blood centers better manage supply to meet patient needs and reduce waste 23 Blood filter IMUGARD III Terumo BCT for blood bags MedicalExpo IMUGARD to Help Strained US Platelet Supply Meet Growing Need LAKEWOOD Colo Feb 16 2023 PRNewswire Today Terumo Blood and Cell Technologies announces US Food and Drug Administration FDA clearance and official launch of its IMUGARD WB Platelet Pooling Set which supports extended shelf life of whole bloodderived platelets from five days to seven days 1 The IMUGARD WB PLT Platelet Pooling Set is intended to be used to leukocytereduce pool and store whole bloodderived platelets For platelets prepared through manual methods leukoreduction and pooling occur on Day 1 the day after whole blood collection and processing with subsequent platelet storage up to Day 7 in the Terumo BCT ELP storage bag when used with FDAcleared or approved Imugard 2023 Terumo BCT IMUGARD enables extended shelf life of platelets from the standard five days to seven days 1 This can help blood centers better surat fussilat manage supply to meet patient needs and reduce waste 23 Most of the platelets in the United States are currently collected by apheresis IMUGARD now gives blood centers another product choice to help them recoup Terumo Blood and Cell Technologies IMUGARD Platelet Pooling Set 5 510K SUMMARY US Food and Drug Administration IMUGARD WB PLT Platelet Pooling Set Terumo BCT Terumos IMUGARD Platelet Pooling Set cleared by FDA IMUGARD opens the possibility for US blood centres to use the platelets from their whole blood donations to increase the number of platelets available for transfusion We are the first company to provide sevenday shelf life of both apheresis and whole bloodderived platelets in the US adding flexibility to the platelet supply PDF Terumo Blood and Cell Technologies IMUGARD Platelet AdvaMed IMUGARD WB PLT Platelet Pooling Set is intended to be used to leukocytereduce pool and store wholebloodderived platelets Terumo Blood and Cell Technologies IMUGARD Platelet Pooling Set Technologies IMUGARD opens the possibility for US blood centers to use the platelets from their whole blood donations to increase the number of platelets available for transfusion We are the first company to provide sevenday shelf life of both apheresis and whole bloodderived platelets in the US adding flexibility to the platelet BK210658 IMUGARD WB PLT Platelet Pooling Set FDA Intended Use Statement IMUGARD WB PLT Platelet Pooling Set is intended to be used to leukocytereduce pool and store wholebloodderived platelets for up to 7 days when used with FDAcleared or approved bacterial detection tests Leukoreduction and pooling occur on Day 1 the day after whole blood collection raja 89 slot login and processing with subsequent
biosekuriti
pelanet77
