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Found 10 results
510(k) Data Aggregation
K Number
K992145Device Name
ECOMED SCALP VEIN SET
Manufacturer
GREINER MEDITECH, INC.
Date Cleared
1999-10-14
(112 days)
Product Code
FPA, FOZ
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
GREINER MEDITECH, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Ecomed® Scalp Vein Set is a winged blood collection needle with a tubing used for the collection of venous blood.
Device Description
The Ecomed® Scalp Vein Set is a sterile winged needle bonded to a flexible tubing with a female luer adapter. The female luer is provided with a protective cap on the end.
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K Number
K992244Device Name
GREINER MINICOLLECT COAGULATION BLOOD COLLECTION TUBE
Manufacturer
GREINER MEDITECH, INC.
Date Cleared
1999-07-26
(24 days)
Product Code
JKA
Regulation Number
862.1675Why did this record match?
Applicant Name (Manufacturer) :
GREINER MEDITECH, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Greiner MiniCollect® is a non-sterile, non-evacuated blood collection device containing a 3.2% sodium citrate solution, intended to collect, transport, and process whole blood for coagulation testing.
The MiniCollect® Coagulation tube is intended for citrate anticoagulated whole blood samples for Coagulation Assays.
Device Description
The Greiner MiniCollect® is a non-sterile, non-evacuated blood collection device containing a 3.2% sodium citrate solution, intended to collect, transport, and process whole blood for coagulation testing.
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K Number
K991843Device Name
GREINER MINICOLLECT LITHIUM HEPARIN GEL BLOOD COLLECTION TUBE
Manufacturer
GREINER MEDITECH, INC.
Date Cleared
1999-06-25
(28 days)
Product Code
JKA
Regulation Number
862.1675Why did this record match?
Applicant Name (Manufacturer) :
GREINER MEDITECH, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
To collect, transport, separate and process capillary blood for testing plasma in the clinical laboratory.
Device Description
The Greiner MiniCollect® is a non-sterile, non-evacuated blood collection device containing lithium heparin anticoagulant and an inert acrylic barrier material, intended to collect, transport, separate and process capillary blood for testing serum.
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K Number
K983952Device Name
GREINER VACUETTE BLOOD COLLECTION TUBE
Manufacturer
GREINER MEDITECH, INC.
Date Cleared
1998-12-28
(53 days)
Product Code
JKA
Regulation Number
862.1675Why did this record match?
Applicant Name (Manufacturer) :
GREINER MEDITECH, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
To collect, transport, store and process blood for testing serum in the clinical laboratory. In addition, tubes are suitable for therapeutic drug monitoring.
Device Description
The Greiner VACUETTE® blood collection tube with clot activator and gel separator is an evacuated blood collection device containing a clot activator and an inert polymeric barrier material.
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K Number
K982998Device Name
GREINER MINICOLLECT SERUM GEL BLOOD COLLECTION TUBE
Manufacturer
GREINER MEDITECH, INC.
Date Cleared
1998-10-21
(55 days)
Product Code
JKA
Regulation Number
862.1675Why did this record match?
Applicant Name (Manufacturer) :
GREINER MEDITECH, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
To collect, transport, separate and process capillary blood for testing serum in the clinical laboratory.
Device Description
The Greiner MiniCollect® is a non-sterile, non-evacuated blood collection device containing a clot activator and an inert acrylic barrier material, intended to collect, transport, separate and process capillary blood for testing serum.
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K Number
K982999Device Name
GREINER MINICOLLECT EDTA BLOOD COLLECTION TUBE
Manufacturer
GREINER MEDITECH, INC.
Date Cleared
1998-10-16
(50 days)
Product Code
JKA
Regulation Number
862.1675Why did this record match?
Applicant Name (Manufacturer) :
GREINER MEDITECH, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
To collect, transport, store, and evaluate capillary blood specimens for hematology and lead tests.
Device Description
The Greiner MiniCollect® EDTA K3 tube is a non-sterile, non-evacuated blood collection device containing EDTA K3 anticoagulant additive, and is intended for use in evaluations of capillary blood specimens. The Greiner MiniCollect® tube cap is made from rubber and has "cross-cuts" to allow for direct collection into and sampling from the tube without having to remove the cap.
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K Number
K981619Device Name
VACUETTE MULTIPLE SAMPLE LUER ADAPTER
Manufacturer
GREINER MEDITECH, INC.
Date Cleared
1998-07-15
(70 days)
Product Code
FMI
Regulation Number
880.5570Why did this record match?
Applicant Name (Manufacturer) :
GREINER MEDITECH, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For use in venous blood collection with attached butterfly needle or luer needle.
Device Description
The Greiner Vacuette® Multiple Sample Luer Adapter is a device of which one end is a plastic male luer adapter and the other end is a sharpened stainless steel needle. The needle end of the luer adapter is epoxy bonded to the plastic upper end (hub) and is covered by a rubber sheath. The luer adapter is threaded into a needle holder for the purposes of attaching a butterfly needle for use in venous blood collection. The luer adapter is a sterile, single-use disposable device.
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K Number
K980768Device Name
VACUETTE HOLDEX
Manufacturer
GREINER MEDITECH, INC.
Date Cleared
1998-04-09
(41 days)
Product Code
FMI
Regulation Number
880.5570Why did this record match?
Applicant Name (Manufacturer) :
GREINER MEDITECH, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
To be used in routine venipuncture procedures using butterfly needles and/or hypodermic luer needles.
Device Description
The VACUETTE® Holdex® Holder is a single-use disposable plastic device to be used in routine venipuncture procedures using butterfly needles or luer needles. Sterile and non-sterile versions are available. The sterile version of VACUETTE® Holdex® is manufactured from polystyrene plastic and is sterilized by electronic beam. The non-sterile version is autoclavable and is manufactured from polycarbonate plastic.
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K Number
K974873Device Name
VACUETTE (MULTI-USE HOLDER)
Manufacturer
GREINER MEDITECH, INC.
Date Cleared
1998-02-05
(38 days)
Product Code
JKA
Regulation Number
862.1675Why did this record match?
Applicant Name (Manufacturer) :
GREINER MEDITECH, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
To be used in routine venipuncture procedures
Device Description
non-sterile reusable plastic device to be used in routine venipuncture procedures.
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K Number
K973620Device Name
VACUETTE MULTI-SAMPLE NEEDLE
Manufacturer
GREINER MEDITECH, INC.
Date Cleared
1997-12-17
(85 days)
Product Code
FMI
Regulation Number
880.5570Why did this record match?
Applicant Name (Manufacturer) :
GREINER MEDITECH, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For use in venous blood collection
Device Description
a tubular stainless steel device sharpened at both ends, one end to withdraw blood, and the other end to be threaded into a needle holder which is used to guide the needle into an evacuated blood collection tube.
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