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510(k) Data Aggregation
K Number
K111424Device Name
VACUETTE PREMIUM SAFETY NEEDLE SYSTEM TUBE-TOUCH
Manufacturer
Date Cleared
2011-07-29
(67 days)
Regulation Number
880.5570Why did this record match?
Applicant Name (Manufacturer) :
MEDPRO SAFETY PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The VACUETTE® PREMIUM Safety Needle System Tube-Touch is used in routine venipuncture procedures. The Needle System is designed with an integrated, multiple sample needle and safety shield. The safety shield is automatically activated and released upon insertion of the first blood collection tube and covers the needle immediately following blood collection from patient. The product is to be used by appropriately trained healthcare professionals only in accordance with these instructions.
Device Description
The VACUETTE® PREMIUM Safety Needle System Tube-Touch is a single-use, sterile needle system, non-toxic, designed with an integrated, multiple use drawing needle and safety shield to provide protection against needlestick injury during venipuncture. This device has no components made of dry natural rubber.
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K Number
K102010Device Name
VACUETTE PREMIUM SAFETY BLOOD COLLECTION SET
Manufacturer
Date Cleared
2010-11-19
(126 days)
Regulation Number
880.5570Why did this record match?
Applicant Name (Manufacturer) :
MEDPRO SAFETY PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
VACUETTE® PREMIUM Safety Blood Collection Set is used in routine venipuncture procedures. It is used for blood collection. The safety shield is activated automatically to cover the needle immediately following blood collection thus preventing accidental needlestick injury.
Device Description
The Vacuette Premium Safety Blood Collection Set is a single use, individually wrapped, sterile winged blood collection needle with an integrated needle and safety shield bonded to a flexible tubing with a female luer adapter allowing the set to be used with a luer system (e.g. Holdex®). It is available with optional Luer Adapter and / or Luer Adapter + Holder. The device is free of PVC, DEHP, Latex.
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K Number
K072602Device Name
VACUETTE PREMIUM SAFETY NEEDLE SYSTEM
Manufacturer
Date Cleared
2008-06-18
(278 days)
Regulation Number
880.5570Why did this record match?
Applicant Name (Manufacturer) :
MEDPRO SAFETY PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The VACUETTE® Premium Safety Needle System is used in routine venipuncture procedures. The holder is designed with an integrated, multiple sample needle and safety shield. Upon insertion of the first blood collection tube, the safety shield is automatically released. The safety shield covers the needle immediately following blood collection from the patient. The product is to be used by appropriately trained healthcare professionals only in accordance with these instructions.
Device Description
The VACUETTE® PREMIUM Safety Needle System is a single use, sterile holder designed with an integrated, multiple sample needle and safety shield to provide protection against needlestick injury during venipuncture.
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