Address:465 State Rt 17,Ramsey,NJ,07446,US
Device Description : The Genesis Rapid Weld STW is a medical device used in laboratories, designed fo The Genesis Rapid Weld STW is a medical device used in laboratories, designed for the purpose of making sterile connections in PVC tubing in blood processing applications. The device enables fluid transfer while maintaining a closed system without the need for a consumable (disposable wafer).
Device Class : 2
Duns Number: 141091095
Premarket Exempt : No
Prescription Use : No
Device Description : The TCD B40 is a bench top, portable device intended for use by appropriately tr The TCD B40 is a bench top, portable device intended for use by appropriately trained and qualified personnel in hospital/laboratory/clinical settings for the purpose of making sterile connections of 3.9 mm to 4.5 mm PVC tubing in blood processing applications.
Device Class : 2
Duns Number: 141091095
Premarket Exempt : No
Prescription Use : No
Device Description : The Genesis RapidWeld II STW, model GRW-430-02, is a medical device used in labo The Genesis RapidWeld II STW, model GRW-430-02, is a medical device used in laboratories, designed for the purpose of making sterile connections in PVC tubing in blood processing applications. The device enables fluid transfer while maintaining a closed system without the need for a consumable (disposable wafer).
Device Class : 2
Duns Number: 141091095
Premarket Exempt : No
Prescription Use : Yes
Device Description : The TCD B40 Wafer Assembly consists of a copper wafer and a plastic holder. The The TCD B40 Wafer Assembly consists of a copper wafer and a plastic holder. The plastic holder is color coded to assist the operator with proper placement/insertion.The wafer assembly is placed in the device prior to the weld process. During the welding process the copper wafer is separated from the plastic holder, and after welding is completed, both the holder and wafer are removed from the device and discarded. The wafers are one-time use only and cannot be reused. The TCD B40 device will not operate without a wafer assembly inserted and will not operate with a used wafer. The TCD B40 wafer assemblies are packaged in boxes containing 240 wafer assemblies in each box referred to as a case.
Device Class :
Duns Number: 141091095
Premarket Exempt : No
Prescription Use : No
Device Description : The Blade Module consists of a stainless steel blade that cuts the PVC tube segm The Blade Module consists of a stainless steel blade that cuts the PVC tube segments. The Blade Module is designed with a built in service meter to record the number of welds performed on the device. This feature monitors the usage endured by the Blade Module. The operator is notified when the Blade Module requires replacement. If the operator fails to respond to the warning message and replace the Blade Module the Genesis RapidWeld STW, Model GRW-430 will not operate once the Blade Module weld cycle limit is reached. Operation will resume once a replacement Blade Module is installed.
Device Class :
Duns Number: 141091095
Premarket Exempt : No
Prescription Use : No
Device Description : The Blade Module consists of a stainless steel blade that cuts the PVC tube segm The Blade Module consists of a stainless steel blade that cuts the PVC tube segments. The Blade Module is designed with a built in service meter to record the number of welds performed on the device. This feature monitors the usage endured by the Blade Module. The operator is notified when the Blade Module requires replacement. If the operator fails to respond to the warning message and replace the Blade Module the Genesis Rapid Weld STW will not operate once the Blade Module weld cycle limit is reached. Operation will resume once a replacement Blade Module is installed.
Device Class :
Duns Number: 141091095
Premarket Exempt : No
Prescription Use : No
Device Description : The Blade Module consists of a stainless steel blade that cuts the PVC tube segm The Blade Module consists of a stainless steel blade that cuts the PVC tube segments. The Blade Module is designed with a built in service meter to record the number of welds performed on the device. This feature monitors the usage endured by the Blade Module. The operator is notified when the Blade Module requires replacement. If the operator fails to respond to the warning message and replace the Blade Module the Genesis Rapid Weld STW will not operate once the Blade Module weld cycle limit is reached. Operation will resume once a replacement Blade Module is installed.
Device Class :
Duns Number: 141091095
Premarket Exempt : No
Prescription Use : No
Device Description : The TCDB40 Wafer Assembly consists of a copper wafer and plastic holder. The pla The TCDB40 Wafer Assembly consists of a copper wafer and plastic holder. The plastic holder is color coded to assist the operator with proper placement/insertion. The wafer assembly is placed in the TCDB40 Sterile Tube Welding device prior to the weld process. The copper wafer is separated from the plastic holder during the welding process and after welding is completed both the plastic holder and the copper wafer are removed from the device and discarded. The wafers are single use only and cannot be reused. The TCDB40 Sterile Tube Welding device will not operate without a wafer assembly inserted and will not operate with a used a wafer. The TCDB40 wafer assemblies are packaged in 8 plastic trays. Each tray has 25 individual wafer assemblies. Each box referred to as a case has a total of 200 individual TCDB40 wafer assemblies.
Device Class :
Duns Number: 141091095
Premarket Exempt : No
Prescription Use : No