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510(k) Data Aggregation
K Number
K162562Device Name
OPT-SHIELD AIR, SUPINE; OPT-SHIELD, LITHOTOMY
Manufacturer
Date Cleared
2017-03-17
(184 days)
Product Code
Regulation Number
870.5900Why did this record match?
Applicant Name (Manufacturer) :
BCG MEDICAL, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Opt-Shield AIR Convection Warming technology is intended to prevent and treat hypothermia. In addition, the temperature management system can be used to provide patient thermal comfort when conditions exist that may cause patient to become too cold.
Device Description
Proposed device: Opt-Shield™ AIR. SAFE Patient-Handling System for Surgical Patient: The proposed Opt-Shield AIR blanket consists of three layers of material: bottom layer nylon impermeable to air (non-contact), middle layer plastic with predetermined holes (non-contact), and top layer polypropylene (in contact with the patient) with microscopic holes (intrinsic to the fabric) throughout the fabric. The three layers are sewn together to create air channels to allow air distribution evenly throughout the blanket to minimize heat reduction. The warm air circulates within blanket and delivers warm air around the patient's body through perforations in the patient side layer of the blanket. The distribution of air is designed to equally deliver air at the similar temperature air at various blanket locations. It has one hose port for receiving warm air.
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