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510(k) Data Aggregation
K Number
K153388Device Name
IMPROSAFE Blood Collection Set with Pre-attached Holder, IMPROVACUTER Blood Collection Set Pre-attached Holder, IMPROSAFE Blood Collection Set, IMPROVACUTER Blood Collection Set, IMPROSAFE Multi Sample Needle, IMPROSAFE Multi Sample Needle (Flashback), IMPROVACUTER Multi Sample Needle
Manufacturer
Date Cleared
2016-06-07
(197 days)
Product Code
Regulation Number
880.5570Why did this record match?
Applicant Name (Manufacturer) :
GUANGZHOU IMPROVE MEDICAL INSTRUMENTS CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The IMPROSAFE® Blood Collection Sets with Pre-attached to be used with evacuated blood collection tube for the collection of venous blood. The safety shield is intended to aid in the protection against accidental needle stick injury.
The IMPROSAFE® Multi-Sample Needles are intended to be used with evacuated blood collection tube for the collection of venous blood. The safety shield is intended to aid in the protection against accidental needle stick injury.
The IMPROVACUTER® Blood Collection Sets are intended to be used with evacuated blood collection tube for the collection of venous blood.
The IMPROSAFE® Blood Collection Sets are intended to be used with evacuated blood collection tube for the collection of venous blood. The safety shield is intended to aid in the protection against accidental needle stick injury.
The IMPROVACUTER® Blood Collection Sets with Pre-attached holder are intended to be used with evacuated blood collection tube for the collection of venous blood.
The IMPROSAFE® Multi-Sample Needles (Flashback) are intended to be used with evacuated blood collection tube for the collection of venous blood. The safety shield is intended to aid in the protection against accidental needle stick injury.
The IMPROVACUTER® Multi-Sample Needles are used with holder and vacuum blood collection tube for the venous blood collection.
Device Description
The proposed devices are blood collection sets form a channel between patient's vein and the evacuated blood collection tube intended for collection of blood. They are available in different configurations as follows:
IMPROSAFE® Blood Collection Set with Pre-attached holder: Patient-End Needle, Non-Patient End Needle, Flexible Tubing, Pre-attached Holder, Safety Mechanism, Visible Flash Back
IMPROSAFE® Blood Collection Set: Patient-End Needle, Non-Patient End Needle, Flexible Tubing, N.A., Safety Mechanism, Visible Flash Back
IMPROVACUTER® Blood Collection Set with Pre-attached Holder: Patient-End Needle, Non-Patient End Needle, Flexible Tubing, Pre-attached Holder, N.A., Visible Flash Back
IMPROVACUTER® Blood Collection Set: Patient-End Needle, Non-Patient End Needle, Flexible Tubing, N.A., N.A., Visible Flash Back
IMPROSAFE® Multi Sample Needle: Patient-End Needle, Non-Patient End Needle, N.A., Pre-attached Holder, Safety Mechanism, N.A.
IMPROSAFE® Multi Sample Needle (Flashback): Patient-End Needle, Non-Patient End Needle, N.A., Pre-attached Holder, Safety Mechanism, Visible Flash Back
IMPROVACUTER® Multi Sample Needle: Patient-End Needle, Non-Patient End Needle, N.A., N.A., N.A., N.A.
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K Number
K093910Device Name
IMPROVACUTER GEL & CLOT ACTIVATOR TUBE
Manufacturer
Date Cleared
2010-07-12
(202 days)
Product Code
Regulation Number
862.1675Why did this record match?
Applicant Name (Manufacturer) :
GUANGZHOU IMPROVE MEDICAL INSTRUMENTS CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
IMPROVACUTER Gel & Clot Activator Tube is a single used to collect, transport, separate, and process venous blood specimens to obtain serum for clinical chemistry and immunology assays. It is used in settings where a venous blood sample is collected by a trained healthcare worker. For in vitro diagnostic use.
Device Description
The IMPROVACUTER® Gel & Clot Activator Tube is sterile, plastic, evacuated blood collection tube. The tube consists of (1) a closure assembly, (2) a silica clot activator, (3) a Barrier Gel and (4) a plastic tube. The specimens are used for clinical laboratory assays involving the use of patient serum.
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