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510(k) Data Aggregation
K Number
K982241Device Name
BETATRANS INTRAOP I AND II MODEL NUMBERS DS100X AND DS10XX
Manufacturer
DUXBURY SCIENTIFIC INC.
Date Cleared
1998-11-30
(158 days)
Product Code
CAC
Regulation Number
868.5830Why did this record match?
Applicant Name (Manufacturer) :
DUXBURY SCIENTIFIC INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Betatrans Intraoperative Autotransfusion System is designed for the collection and reinfusion of intraoperative drainage blood collected intraoperatively. The system is intended to reduce or eliminate the need for transfusion of homologous blood, which can carry a variety of infectious agent including Hepatitis or HIV.
Device Description
Not Found
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K Number
K951592Device Name
BETATRANS I AND II
Manufacturer
DUXBURY SCIENTIFIC INC.
Date Cleared
1996-03-04
(333 days)
Product Code
CAC
Regulation Number
868.5830Why did this record match?
Applicant Name (Manufacturer) :
DUXBURY SCIENTIFIC INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
To collect and infuse blood lost by a patient due to orthopaedic surgery.
Device Description
The Betatrans Orthopaedic Autotransfusion System consists of a stainless steel trocar and PVC wound drain available in 1/8", 3/16 and 1/4" ID sizes the line is connected to a PVC blood collection line with a universal Y connector and pinch clamp which connects to a 800ml PETG blood collection chamber with integral 260 micron gross clot pre-filter and either one or two female halves of a patented"Duxbury Connector" bonded to the bottom of the chamber. one or two preconnected sterile 800ml blood bag. A bag contains at it's top a male "Duxbury Connector" and a transfusion port. A safety cap covers the transfusion port and is available for use as a cover for the male connector once separated from the collection chamber. The bags male and female connector are shipped in a locked position. In this position a valve is located in each half of the connector remains closed, preventing fluid or air to pass in either direction. A vacuum tube assembly consisting of a 0.45 micron bacterial air filter, one way outflow valve, pinch clamp, and a five in one suction connector for venting of the chamber, as air is displaced by incoming blood. A vent cap assembly with a tethered screw on cap, one way inflow valve and a 0.45 micron filter to allow venting of the chamber during transfer of blood to the blood bag(s).
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