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510(k) Data Aggregation
K Number
K031151Device Name
TS3 TUBING SET
Manufacturer
Date Cleared
2003-06-26
(77 days)
Product Code
Regulation Number
870.4210Why did this record match?
Applicant Name (Manufacturer) :
GLOBAL BLOOD RESOURCES, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The TS3 Tubing Set serves as a fluid delivery pathway for anticoagulated whole blood from extracorporeal circuits to be delivered to and from a hemoconcentrator. The TS3 Tubing Set may be used in either of the following situations: a) As a conduit for conventional hemoconcentration during Cardiopulmonary Bypass surgery, or b) As a conduit for use with the HEMOBAG™ Blood Salvage Device as a hemoconcentration reservoir.
Device Description
The TS3 Tubing Set serves as a fluid delivery pathway for anticoagulated whole blood from extracorporeal circuits to be delivered to and from a hemoconcentrator. The TS3 Tubing set may be used as a conduit with conventional hemoconcentration during Cardiopulmonary Bypass Surgery or as a conduit for use with the HEMOBAG "" Blood Salvage Device when the bag is used as a hemoconcentrating reservoir. The TS3 Tubing Set is designed with ¼" ID PVC tubing with standard dialysis luer fittings for connection to a commercially available hemoconcentrator. The TS3 Tubing Set is also designed with quick connect/disconnect fittings for easy attachment to the HEMOBAG™ Blood Salvage Device Reservoir. The tubing sets are manufactured with appropriately sized snap closing/occluding the tubing when appropriate.
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K Number
K031150Device Name
HEMOBAG, MODEL HBBSD2000
Manufacturer
Date Cleared
2003-06-23
(74 days)
Product Code
Regulation Number
870.4400Why did this record match?
Applicant Name (Manufacturer) :
GLOBAL BLOOD RESOURCES, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The HEMOBAG™ is a blood circulating storage reservoir designed to collect anticoagulated whole blood salvaged from extracorporeal circuits after the patient has been disconnected from the circuit. When used in connection with the TS3 Tubing Set and a commercially available hemoconcentrator, the HEMOBAG™ serves as a reservoir for circulating and hemoconcentrating blood in a closed circuit recovery loop.
Device Description
The HEMOBAG™ Blood Salvage Device is a storage reservoir for blood that can be held, circulated and hemoconcentrated. It is designed for use in salvaging anticoagulated whole blood from extracorporeal circuits. When used in conjunction with a TS3 Tubing Set and a commercially available hemoconcentrator, the HEMOBAG™ serves as a hemoconcentrating reservoir for use in a closed circuit recovery loop for removal of excess plasma water and low molecular weight solutes. The richly concentrated, anticoaqulated, autologous whole blood is then quickly made available to the patient for gravity transfusion.
The HEMOBAG™ is designed with a universal (1/4" – 3/8″) stepped connector on the arterial infusion port to allow lines of varying sizes to be attached to the bag. The inlet and outlet ports of the bag are designed with quick connect/disconnect ¼" connectors to mate with the TS3 Tubing set for fluid delivery to and from the hemoconcentrator. The HEMOBAG™ is equipped with a needleless port for ease of access. The HEMOBAG™ has been designed with a spike port to facilitate gravity transfusion. A baffle has been positioned inside the bag to allow the blood from the hemoconcentrator to enter the bag and circulate toward the top of the bag and down again to the outlet port allowing proper mixing and flow during hemoconcentration.
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