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510(k) Data Aggregation
K Number
K062794Device Name
PRN THERMALCARE, MODEL 3000
Manufacturer
AMERICAN HEALTHCARE PRODUCTS, INC.
Date Cleared
2006-12-07
(80 days)
Product Code
DWJ
Regulation Number
870.5900Why did this record match?
Applicant Name (Manufacturer) :
AMERICAN HEALTHCARE PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PRN ThermalCare patient warming system is intended to aid in the maintenance of patient normal thermia (maintaining normal body temperature of 36C) before, during and after the perioperative experience (surgery) for Pediatric and Adult patients. Conductive warming temperatures for the patient are selected by physicians (anesthesiologist or nurse anesthetist) or according to facility hypothermia protocol. Pressure reduction is achieved within the pad design. The pressure reducing properties are effective for Patients up to 500 1bs./225k
Device Description
The PRN ThermalCare patient warming system, Model 3000 system includes a pressure reducing, thermal regulated mattress, which is placed beneath the patient, and a separate control unit. The mattress contains a carbon fiber heating element for which the control unit, when connected, supplies low voltage DC current, providing low level conductive heat (preset between 36°C and 40°C) to the patient.
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K Number
K963211Device Name
UNISEAL GLOVES (LOW PROTEIN,POWDER FREE)
Manufacturer
AMERICAN HEALTHCARE PRODUCTS, INC.
Date Cleared
1996-11-22
(98 days)
Product Code
LYY
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
AMERICAN HEALTHCARE PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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