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510(k) Data Aggregation
K Number
K130068Device Name
DISMOUNTED MEDICAL & SUPPLEMENTAL OXYGEN SYSTEM (DMOS)
Manufacturer
ESSEX INDUSTRIES, INC. D/B/A ESSEX CRYOGENICS OF M
Date Cleared
2013-07-19
(189 days)
Product Code
BYJ
Regulation Number
868.5655Why did this record match?
Applicant Name (Manufacturer) :
ESSEX INDUSTRIES, INC. D/B/A ESSEX CRYOGENICS OF M
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The DMOS is intended to convert liquid oxygen to gaseous oxygen for delivery to a patient and/or for delivery to rescue personnel to supplement environmental oxygen at high altitudes while being carried by a rescue personnel at one-half (0.5) to fifteen (15) liters per minute (LPM) and fifty (50) pounds per square inch gauge (psig).
Device Description
The DMOS, when filled with liquid oxygen, will be used to provide medical oxygen treatment to injured personnel or provide supplemental oxygen to operator during dismounted operations above 10,000 feet MSL. The DMOS provides for storing of 1.4 liters of liquid oxygen and converting this liquid into its gaseous state. The gaseous oxygen is capable of being delivered in controlled amounts to provide medical treatment to injured patients and uncontrolled amounts to drive respiratory medical devices or supplemental oxygen in high altitude. The DMOS is capable of being filled with liquid oxygen from the Oxygen Generator System (OGS) and with current liquid oxygen storage/ filling stations. The DMOS contains a thermally insulated container of liquid oxygen (LOX) that is intended to supplement gases to be inhaled by a patient. The DMOS supports medical devices provided by the user including masks, cannulas, and Bag Valve Mask (BVM) being attached to the flow control patient outlets. The DMOS is portable and can be carried onboard, tied down, transported and operationally perform on various aircraft and ground vehicles. The DMOS converts liquid oxygen from its insulated container through its heat exchanger into gaseous oxygen and finally the gaseous oxygen is available for distribution from an outlet port on the user interface.
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