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510(k) Data Aggregation
K Number
K040856Device Name
RAPID AID INSTANT DISPOSABLE INFANT HEEL WARMER
Manufacturer
RAPID AID LTD.
Date Cleared
2004-05-03
(31 days)
Product Code
MPO
Regulation Number
890.5710Why did this record match?
Applicant Name (Manufacturer) :
RAPID AID LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Rapid Aid Infant Heel Warmer is primarily used in hospitals, Doctor's offices, and other healthcare facilities. It is an instant warm pack intended to be used on an infant's heel to increase blood circulation to the area to aid in the drawing of blood for analysis. It is a single use, non-toxic, non-sterile, disposable warmer.
Device Description
The Rapid Aid Infant Heel Warmer is a self contained unit comprised of a flexible, poly/nylon outer pouch containing:
- a) A flexible, perforated, polyethylene/polyester inner pouch that holds the liquid solution.
- b) Liquid solution of food grade sodium acetate and water contained in a).
- c) Minute crystals of sodium acetate.
An adhesive tape is attached to the top of the unit. The unit is activated by squeezing firmly on the inner fluid pouch, this will cause the inner perforated pouch to activate. Rapid crystallization occurs when the liquid contents are exposed to the minute crystals of sodium acetate contained within the poly/nylon outer pouch. This exothermic reaction causes the unit to heat up to 105 degrees F. The adhesive tape strip is used to hold the warmer in place on the infant's heel.
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