Search Results
Found 2 results
510(k) Data Aggregation
K Number
K030573Device Name
BD VACUTAINER PUSH BUTTON BLOOD COLLECTION SET, MODELS 367338, 367344, 367336, 367342, 367335, 367341
Manufacturer
BD VACUTAINER SYSTEMS PREANALYICAL SOLUTIONS
Date Cleared
2003-05-08
(73 days)
Product Code
JKA
Regulation Number
862.1675Why did this record match?
Applicant Name (Manufacturer) :
BD VACUTAINER SYSTEMS PREANALYICAL SOLUTIONS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The BD Vacutainer™ Push Button Blood Collection Set is a sterile, multiplesample, single-use winged blood collection set intended for venipuncture to obtain blood specimens from patients.
The BD Vacutainer™ Push Button Blood Collection Set is also indicated for the intravenous administration of fluids as indicated in 21 CFR §880.5440. It may be used for any patient population with consideration given to patient size and appropriateness for the solution being infused and duration of therapy.
The recommended use of the device is to activate the needle prior to removal from the venipuncture site. The retraction of the intravenous (IV) end of the needle aids in the prevention of accidental needlestick injury.
Device Description
The BD Vacutainer™ Push Button Blood Collection Set is for venous blood collection and IV administration. It contains a needle that will retract into the body of the device when a button is depressed, helping to prevent accidental needle sticks.
Ask a Question
K Number
K023075Device Name
BD VACUTAINER PLUS SST SERUM SEPARATOR TUBE
Manufacturer
BD VACUTAINER SYSTEMS PREANALYICAL SOLUTIONS
Date Cleared
2002-11-25
(70 days)
Product Code
JKA
Regulation Number
862.1675Why did this record match?
Applicant Name (Manufacturer) :
BD VACUTAINER SYSTEMS PREANALYICAL SOLUTIONS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Vacutainer™ PLUS SST™ Tube is a plastic evacuated blood collection tube with silica clot activator and gel that provides a means of collecting, transporting, separating, and processing blood in a closed tube. Blood collected in a Vacutainer™ PLUS SST™ Tube is primarily used for clinical laboratory testing in chemistry using patient serum, but may be used for other assays requiring serum specimens as determined by the laboratory. In addition, the Vacutainer™ PLUS SST™ Tube is compatible with many commonly used therapeutic drugs therefore suitable for therapeutic drug monitoring (TDM). Blood can be collected, processed and stored in a Vacutainer™ PLUS SST™ tube for at least 24 hours for therapeutic drug monitoring without large losses in recovery.
Device Description
The Vacutainer™ PLUS SST™ Tubes are sterile, plastic, evacuated blood collection tubes. The Vacutainer™ PLUS SST™ Tube consists of: (1) a closure assembly, (2) an inert polyester gel barrier, (3) silica clot activator, and (4) a silicone surfactant coated plastic tube. The specimen is centrifuged and the barrier material forms at the serum/blood clot interface, mechanically separating the serum from cells. The serum portion is used for clinical laboratory assays involving the use of patient serum.
Ask a Question
Page 1 of 1