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510(k) Data Aggregation
K Number
K050524Device Name
EZ-IV MEDICAL PAD WARMING UNIT, MODEL 1000
Manufacturer
MARDA MEDICAL, INC.
Date Cleared
2005-09-14
(196 days)
Product Code
IRQ
Regulation Number
890.5950Why did this record match?
Applicant Name (Manufacturer) :
MARDA MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The EZ-IV Medical Pad Warming Unit is intended to warm alcohol and povidone iodine skin cleansing pads for use in gaining venous access during intravenous fluid and / or medication administration and to facilitate phlebotomy procedures.
Device Description
The EZ-IV Medical Pad Warming Unit, is a compact, portable, tabletop size medical device, used to warm factory sealed medical prep pads (alcohol and povidone iodine), with a pre-set maximum temperature of 55° C. A lid covers the unit to minimize any heat loss from the medical pads. Inside the unit are four individual compartments, in which the sealed pads are placed. Each compartment has it's own, inner lid. The front of the device has a membrane keypad to control the device function.
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