15 results
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38ms
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Sources: EU EUDAMED, US FDA
RapidWeld Blade Module Kit
FDA UDI
GENESIS BPS LLC·10866305000254·The Blade Module consists of a stainless steel ...
TCD B40 Wafers
FDA UDI
GENESIS BPS LLC·10866305000278·The TCDB40 Wafer Assembly consists of a copper ...
RapidWeld Blade Module Kit
FDA UDI
GENESIS BPS LLC·10866305000230·The Blade Module consists of a stainless steel ...
Total Containment Device (TCD)
FDA UDI
GENESIS BPS LLC·00866305000219·The TCD B40 is a bench top, portable device int...
Genesis RapidWeld II STW Sterile Tube Welder
FDA UDI
GENESIS BPS LLC·00866305000264·The Genesis RapidWeld II STW, model GRW-430-02,...
RapidWeld Blade Module Kit
FDA UDI
GENESIS BPS LLC·10866305000247·The Blade Module consists of a stainless steel ...
Genesis Tube Stripper
FDA UDI
GENESIS BPS LLC·00866305000288·The Tube Stripper is a “plier-like” tool used t...
TCD B40 Wafers
FDA UDI
GENESIS BPS LLC·10866305000223·The TCD B40 Wafer Assembly consists of a copper...
Genesis RapidWeld STW Sterile Tube Welder
FDA UDI
GENESIS BPS LLC·00866305000202·The Genesis Rapid Weld STW is a medical device ...
Pedi-Pak Pedi-Syringe Filter 35 mL Monoject Syringe Rx Only Genesis BPS, LLC The intended use is to prepare and deliver small aliquots of filtered whole blood, red blood cells, platelets, plasma, and cryoprecipitate for pediatric and or neonatal transfusion.
FDA Enforcement
Class II
·Terminated·Genesis BPS, LLC.·September 24, 2014
Pedi-Pak Pedi-Syringe Filter 30 mL Becton Dickinson Syringe Rx Only Genesis BPS, LLC The intended use is to prepare and deliver small aliquots of filtered whole blood, red blood cells, platelets, plasma, and cryoprecipitate for pediatric and or neonatal transfusion
FDA Enforcement
Class II
·Terminated·Genesis BPS, LLC.·September 24, 2014
Pedi-Pak Pedi-Syringe Filter 60 mL Becton Dickinson/Monoject Syringe Rx Only Genesis BPS, LLC The intended use is to prepare and deliver small aliquots of filtered whole blood, red blood cells, platelets, plasma, and cryoprecipitate for pediatric and or neonatal transfusion
FDA Enforcement
Class II
·Terminated·Genesis BPS, LLC.·September 24, 2014
Pedi-Pak Pedi-Syringe Filter 35 mL Monoject Syringe Rx Only Genesis BPS, LLC The intended use is to prepare and deliver small aliquots of filtered whole blood, red blood cells, platelets, plasma, and cryoprecipitate for pediatric and or neonatal transfusion.
FDA Recall
Terminated
·Genesis BPS, LLC.·Product code BRZ·July 17, 2014
Pedi-Pak Pedi-Syringe Filter 30 mL Becton Dickinson Syringe Rx Only Genesis BPS, LLC The intended use is to prepare and deliver small aliquots of filtered whole blood, red blood cells, platelets, plasma, and cryoprecipitate for pediatric and or neonatal transfusion
FDA Recall
Terminated
·Genesis BPS, LLC.·Product code BRZ·July 17, 2014
Pedi-Pak Pedi-Syringe Filter 60 mL Becton Dickinson/Monoject Syringe Rx Only Genesis BPS, LLC The intended use is to prepare and deliver small aliquots of filtered whole blood, red blood cells, platelets, plasma, and cryoprecipitate for pediatric and or neonatal transfusion
FDA Recall
Terminated
·Genesis BPS, LLC.·Product code BRZ·July 17, 2014