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510(k) Data Aggregation
K Number
K080235Device Name
SAFETY INFUSION SET
Manufacturer
GREINER BIO-ONE VACUETTE NORTH AMERICA
Date Cleared
2008-04-24
(85 days)
Product Code
FMI
Regulation Number
880.5570Why did this record match?
Applicant Name (Manufacturer) :
GREINER BIO-ONE VACUETTE NORTH AMERICA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The VACUETTE® Safety Infusion Set is a single-use, sterile, winged blood collection needle bonded to a flexible tubing with a luer connector. The VACUETTE® Safety Infusion Set is used for blood collection and/or the shortterm infusion of intravenous fluids. The winged needle is designed with a safety shield, which can be activated to cover the needle immediately following venipuncture to aid in the protection against accidental needlestick injury.
Device Description
The VACUETTE® Safety Infusion Set is a single-use, sterile, winged blood collection needle bonded to a flexible tubing with a luer connector. The VACUETTE® Safety Infusion Set is used for blood collection and/or the short-term infusion of intravenous fluids. The winged needle is designed with a safety shield, which can be activated to cover the needle immediately following venipuncture to aid in the protection against accidental needlestick injury. The safety feature is easily operated through the release of a latch mechanism whereby the user slides a winged cover over the needle, as it is removed from the patient. Once the needle is covered, the safety cover locks in place. The VACUETTE® Safety Infusion Set will be available in 2 configurations of needle gauge (21G and 23G) and one tubing length (7.5 inches). The devices are packaged as sterile and are labeled for single use only. There is no ability to clean and reuse these devices. The devices were tested for sterility, pyrogenicity and systemic injection testing and were found to be biocompatible.
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K Number
K042927Device Name
VACUETTE EDTA K3 EVACUATED BLOOD COLLECTION TUBES
Manufacturer
GREINER BIO-ONE VACUETTE NORTH AMERICA
Date Cleared
2005-04-15
(175 days)
Product Code
PJE
Regulation Number
862.1675Why did this record match?
Applicant Name (Manufacturer) :
GREINER BIO-ONE VACUETTE NORTH AMERICA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
VACUETTE® Tubes, Holders and Needles are used together as a system for the collection of venous blood. VACUETTE® EDTA K3 Tubes are used for testing plasma in molecular diagnostics. The performance characteristics of this device have not been established for molecular diagnostic assays in general. Users must validate use of product for their specific molecular diagnostic assay.
Device Description
VACUETTE® Tubes, Holders and Needles are used together as a system for the collection of venous blood. VACUETTE® tubes are used to collect, transport and process blood for testing serum, plasma or whole blood in the clinical laboratory. VACUETTE® EDTA K3 Tubes are used for testing whole blood in molecular diagnostics.
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K Number
K033478Device Name
VACUETTE QUICKSHIELD SAFETY TUBE HOLDER
Manufacturer
GREINER BIO-ONE VACUETTE NORTH AMERICA
Date Cleared
2003-12-29
(56 days)
Product Code
FMI
Regulation Number
880.5570Why did this record match?
Applicant Name (Manufacturer) :
GREINER BIO-ONE VACUETTE NORTH AMERICA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The VACUETTE® QUICKSHIELD Safety Tube Holder is to be used together only with VACUETTE® Multi-Sample Needles and VACUETTE® Blood Collection Tubes as a system in routine venipuncture procedures. This device is designed with a safety shield, which can be activated to cover the needle immediately following venipuncture to aid in the protection against accidental needlestick injury.
Device Description
The VACUETTE® QUICKSHIELD Safety Tube Holder is to be used together only with VACUETTE® Multi-Sample Needles and VACUETTE® Blood Collection Tubes as a system in routine venipuncture procedures. This device is designed with a safety shield, which can be activated to cover the needle immediately following venipuncture to aid in the protection against accidental needlestick injury.
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K Number
K023971Device Name
VACUETTE TRACE ELEMENTS TUBES
Manufacturer
GREINER BIO-ONE VACUETTE NORTH AMERICA
Date Cleared
2003-01-27
(59 days)
Product Code
JKA
Regulation Number
862.1675Why did this record match?
Applicant Name (Manufacturer) :
GREINER BIO-ONE VACUETTE NORTH AMERICA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Greiner VACUETTE® Trace Elements Evacuated Blood Collection Tubes with sodium heparin or no additive are used to collect, transport and process blood for testing plasma, serum, or whole blood for trace elements in the clinical laboratory.
Device Description
VACUETTE® Tubes are used to collect, transport and process blood for testing serum, plasma or whole blood in the clinical laboratory. The VACUETTE® Trace Elements tube with sodium heparin may be used to collect a whole blood/plasma sample. The VACUETTE® Trace Elements tube with no additive may be used to collect a serum sample. The tubes are composed of clear plastic. The caps are roval blue and made of plastic and rubber: the inner cap rings are black and made of plastic. The tubes' size is 13 x 75 mm. 6mL draw. The tubes are equipped with a vacuum tube holder to assist in positioning the product when obtaining blood samples. The vacuum tube holder is composed of plastic.
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K Number
K011699Device Name
VACUETTE EVACUATED BLOOD COLLECTION TUBES
Manufacturer
GREINER BIO-ONE VACUETTE NORTH AMERICA
Date Cleared
2001-06-28
(27 days)
Product Code
JKA
Regulation Number
862.1675Why did this record match?
Applicant Name (Manufacturer) :
GREINER BIO-ONE VACUETTE NORTH AMERICA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
VACUETTE® tubes with sodium heparin are used to collect, transport and process blood for testing plasma or whole blood in the clinical laboratory.
Device Description
VACUETTE® Tubes are used to collect, transport and process blood for testing serum, plasma or whole blood in the clinical laboratory. The VACUETTE® tube with sodium heparin may be used to collect a whole blood/plasma sample. The tube is composed of clear plastic. The cap is made of plastic and rubber. The tube size is 13 x 75 mm. The tube is equipped with a vacuum tube holder to assist in positioning the product when obtaining blood samples. The vacuum tube holder is composed of plastic.
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