Search Results
Found 2 results
510(k) Data Aggregation
K Number
K163295Device Name
Infant Transport Mattress Warmer with Disc
Manufacturer
RAPID AID CORP.
Date Cleared
2017-07-24
(244 days)
Product Code
IMD
Regulation Number
890.5710Why did this record match?
Applicant Name (Manufacturer) :
RAPID AID CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Rapid Aid Infant Transport Mattress Warmer with Disc provides warmth during transport of an infant within the hospital or between hospitals. It is recommended for full-term infants.
Device Description
The Rapid Aid Infant Transport Mattress Warmer with Disc (Infant Transport Mattress) is a rectangular pad that is intended to provide warmth during transport of an infant within a hospital or between hospitals. The single-use disposable device consists of an outer pouch with a liquid solution activated by bending an activator disc; an exothermic reaction warms the Infant Transport Mattress to no higher than 104°F (range 101°F to 104°F) for a dwell time of ≥10 minutes.
Ask a Question
K Number
K150627Device Name
Rapid Aid Instant Disposable Infant Heel Warmer
Manufacturer
RAPID AID CORP.
Date Cleared
2015-05-27
(77 days)
Product Code
MPO
Regulation Number
890.5710Why did this record match?
Applicant Name (Manufacturer) :
RAPID AID CORP.
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 metal disc that can be flexed during activation,
- b) Liquid solution of food grade sodium acetate and water,
- c) Minute crystals of sodium acetate.
An adhesive tape is attached to the top of 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 exothermnic reaction causes the unit to heat up to 104ºF. The adhesive tape strip is used to hold the warmer in place if desired.
Ask a Question
Page 1 of 1