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510(k) Data Aggregation
K Number
K033515Device Name
HUBERPRO SAFETY HUBER INFUSION SET
Manufacturer
COMMAND MEDICAL PRODUCTS
Date Cleared
2004-01-22
(77 days)
Product Code
FPA
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
COMMAND MEDICAL PRODUCTS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The HuberPRO ™ Safety Huber Infusion Set is intended to administer solutions and medications into vascular implant ports. In addition, to minimize the risk of accidental needle stick injury after use, the attached safety guard fully encapulates the needle when manually activated during withdrawal.
Device Description
The device consists of a Protector cap, female Luer lock, PVC tubing, two each 4 inch, or one 8 inch tubing length and ( .3 mm) ID, a pinch clamp, with and without a needle free y- site, a butterfly wing, a safety needle guard, an AISI 304 (19ga., 20ga., 22ga.) stainless steel needle, and a needle sheath.
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