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510(k) Data Aggregation
K Number
K061902Device Name
COSYTHERM, MODELS NCM1, NCM2, NCB1, CCU1, CRU1
Manufacturer
INDITHERM MEDICAL
Date Cleared
2006-12-08
(156 days)
Product Code
DWJ
Regulation Number
870.5900Why did this record match?
Applicant Name (Manufacturer) :
INDITHERM MEDICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Designed for use in the neonatal intensive care unit (NICU), Special Care Baby Unit (SCBU), delivery suite, post-natal wards and during transport, the CosyTherm warming system provides safe and controlled warming to assist newborn infants to maintain normal body temperature. In addition to providing warming, the mattress also includes a pressure relief pad.
Device Description
The Inditherm CosyTherm system consists of a precision temperature control unit that controls and monitors the temperature of a mattress or blanket composed of a carbon polymer material. A pressure relief pad is integrated into the mattress, underneath the flexible warming surface.
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K Number
K051419Device Name
INDITHERM PATIENT WARMING SYSTEM, MODELS MECU1; OTM1; OTM2; GTM1; PTM1; OTB; RB1
Manufacturer
INDITHERM MEDICAL
Date Cleared
2006-04-27
(330 days)
Product Code
DWJ
Regulation Number
870.5900Why did this record match?
Applicant Name (Manufacturer) :
INDITHERM MEDICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Designed for use in the operating room, recovery room, anesthetic room, intensive care, medical and surgical floors, patient transport and emergency department; the Inditherm Patient Warming System provides safe and controlled warming to assist patients to maintain normal body temperature. In addition to providing warming and control, the mattress also provides pressure relief to help prevent pressure sores.
Device Description
The Inditherm Patient Warming System consists of a precision temperature control unit that controls and monitors the temperature of a mattress or blanket composed of a carbon polymer material. A pressure relief pad is integrated into the mattress, underneath the flexible warming surface.
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