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510(k) Data Aggregation
K Number
K051009Device Name
HUBER CLEAR SAFETY INFUSION SET
Manufacturer
Date Cleared
2005-07-12
(82 days)
Product Code
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
NOW MEDICAL DISTRIBUTION, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The NOW Huber Clear™ Safety Infusion Set is a safety IV administration set with a non-coring, ninety-degree, right-angle Huber needle, used to access surgically implanted vascular ports. The Huber needle is used to administer fluids or to withdraw blood. The Huber Clear™ system facilitates safe removal of the needle by encapsulating the needle within the attachment wings to help prevent needlestick injuries when using the device for vascular port access.
Device Description
The NOW Huber Clear™ Safety Infusion Set is a standard non-coring right angle Huber needle and administration set with a needlestick prevention feature. The Huber Clear™ Safety Infusion Set is designed for use with a vascular access infusion system. The NOW Huber Clear™ Safety Infusion Set is fabricated from biocompatible, medical grade materials. The needle is inserted into the vascular access port in a standard manner for fluid infusion or for blood sampling. Removal of the needle is done as with any standard Huber needle, using a one-handed (dominant hand) technique to pull out the needle, and stabilizing the port with the nondominant hand. As the needle is removed, the passive needlestick prevention feature actuates automatically when the users hands are positioned correctly and can be easily seen, felt, and heard by the user to ensure that the needle cover is secure. The NOW Huber Clear™ Safety Infusion Set is supplied sterile and nonpyrogenic, for single use only.
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