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510(k) Data Aggregation
K Number
K032989Device Name
MEDI-HEAT INFANT HEEL WARMER
Manufacturer
MEDIHEAT, INC.
Date Cleared
2003-10-22
(28 days)
Product Code
MPO
Regulation Number
890.5710Why did this record match?
Applicant Name (Manufacturer) :
MEDIHEAT, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
1. MediHEAT Infant Heel Warmer is primarily used in hospitals, Doctor's offices, and other healthcare facilities.
2. Normally, Medical Practitioners squeeze the heels of Infants to increase blood circulation in the area before drawing blood for analyses.
3. The Infant Heel Warmer is used to warm the heel of an Infant to increase blood circulation to the area to facilitate blood sampling.
Device Description
The MediHeat Infant Heel Warmer is a self-contained unit comprised of a flexible Nylon/Polyethylene bag containing the ingredients: a) Food grade sodium acetate, b) Water and c) Activator disk. When the disk is clicked, it activates the sodium acetate solution causing it to pass from the liquid phase to a solid phase (crystallization), making it exothermic. d) An adhesive tape to hold the warmer in place. It heats up to a maximum temperature of up to 105°F and gradually diminishes.
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