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510(k) Data Aggregation
K Number
K014104Device Name
VACUETTE EDTA K2 TUBES
Manufacturer
GREINER VACUETTE NORTH AMERICA, INC.
Date Cleared
2002-02-01
(50 days)
Product Code
PJE
Regulation Number
862.1675Why did this record match?
Applicant Name (Manufacturer) :
GREINER VACUETTE NORTH AMERICA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The VACUETTE® EDTA K2 tube provides a means for collection, processing and transportation of an undiluted plasma specimen in a closed evacuated system. The tube contains spray-dried EDTA, yielding a ratio of 1.8mg/mL of blood when the evacuated tube is filled correctly to its fill volume. The VACUETTE® EDTA K2 tube is used for plasma preparation and is made of plastic for the collection of venous blood which upon centrifugation separates undiluted plasma for use in molecular diagnostic test methods (such as but not limited to PCR - Polymerase Chain Reaction), or other procedures where an undiluted plasma specimen is required as determined by the laboratory.
Device Description
The VACUETTE® EDTA K2 Tube is used for plasma preparation and is made of plastic for the collection of venous blood which upon centrifugation separates undiluted plasma for use in molecular diagnostic test methods (such as but not limited to PCR - Polymerase Chain Reaction), or other procedures where an undiluted plasma specimen is required as determined by the laboratory.
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K Number
K012043Device Name
VACUETTE EDTA K2 GEL TUBES
Manufacturer
GREINER VACUETTE NORTH AMERICA, INC.
Date Cleared
2001-09-24
(87 days)
Product Code
PJE
Regulation Number
862.1675Why did this record match?
Applicant Name (Manufacturer) :
GREINER VACUETTE NORTH AMERICA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The VACUETTE® EDTA K2 Gel tube provides a means for collection, processing and transportation of an undiluted plasma specimen in a closed evacuated system. The tube contains spray-dried EDTA, yielding a ratio of 1.8mg/mL of blood when the evacuated tube is filled correctly to its fill volume, and a gel barrier material. The VACUETTE® EDTA K2 Gel tube is used for plasma preparation and is made of plastic for the collection of venous blood which upon centrifugation separates undiluted plasma for use in molecular diagnostic test methods (such as but not limited to PCR - Polymerase Chain Reaction), or other procedures where an undiluted plasma specimen is required as determined by the laboratory.
Device Description
The VACUETTE® EDTA K2 Gel tube provides a means for collection, processing and transportation of an undiluted plasma specimen in a closed evacuated system. The tube contains spray-dried EDTA, yielding a ratio of 1.8mg/mL of blood when the evacuated tube is filled correctly to its fill volume, and a gel barrier material.
The VACUETTE® EDTA K2 Gel Tube is used for plasma preparation and is made of plastic for the collection of venous blood which upon centrifugation separates undiluted plasma for use in molecular diagnostic test methods (such as but not limited to PCR - Polymerase Chain Reaction), or other procedures where an undiluted plasma specimen is required as determined by the laboratory.
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K Number
K011786Device Name
VACUETTE SAFETY BLOOD COLLECTION SET
Manufacturer
GREINER VACUETTE NORTH AMERICA, INC.
Date Cleared
2001-07-12
(34 days)
Product Code
FMI
Regulation Number
880.5570Why did this record match?
Applicant Name (Manufacturer) :
GREINER VACUETTE NORTH AMERICA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The VACUETTE® Safety Blood Collection Set is a single-use, sterile, winged blood collection needle bonded to a flexible tubing with a female luer adapter. The VACUETTE® Safety Blood Collection Set is used in routine venipuncture procedures. 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 product is to be used by appropriately trained healthcare professionals only in accordance with these instructions.
Device Description
The VACUETTE® Safety Blood Collection Set is a single-use, sterile, winged blood collection needle bonded to a flexible tubing with a female luer adapter. The Winged needle is designed with a safety shield, which can be activated to cover the noodle in houleve inmediately following venipuncture to aid in the protection against accreental in accordance with these instructions. The safety feature is easily operated through the release of a latch mechanism whereby the The Salely leature is easily operator and it is removed from the patient. Once the user slides a wingsu ocatety cover locks in place. This mechanism is substantially needie is covered, the oulony ject® Angel Wing Blood Collection Set. The VACUETTE® Safety Blood Collection Set will be available in 80 configurations to include needle gauge (10 gauge sizes), needle length (2 lengths) and tubing length (4 lengths). The devices are packaged as sterile and are labeled for single use only. There is no ability The devices are pookegoe as ses. The results of biocompatibility data support the to clean and rease theose and include sterility, pyrogenicity and systemic injection testing.
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K Number
K003812Device Name
VACUETTE SPEEDY QUICK-RELEASE HOLDER
Manufacturer
GREINER VACUETTE NORTH AMERICA, INC.
Date Cleared
2001-04-30
(140 days)
Product Code
FMI
Regulation Number
880.5570Why did this record match?
Applicant Name (Manufacturer) :
GREINER VACUETTE NORTH AMERICA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K002777Device Name
VACUETTE WITH PPACK
Manufacturer
GREINER VACUETTE NORTH AMERICA, INC.
Date Cleared
2000-10-05
(29 days)
Product Code
JKA
Regulation Number
862.1675Why did this record match?
Applicant Name (Manufacturer) :
GREINER VACUETTE NORTH AMERICA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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