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510(k) Data Aggregation
K Number
K162811Device Name
MR Conditional CGA 870
Manufacturer
Essex Industries, Inc.
Date Cleared
2017-03-02
(147 days)
Product Code
CAN
Regulation Number
868.2700Why did this record match?
Applicant Name (Manufacturer) :
Essex Industries, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Essex MR Conditional CGA 870 pressure regulators are used with a portable oxygen delivery system intended to provide supplemental oxygen to adults in hospital, sub-acute care, and pre-hospital / ground transport settings. It is offered in models that are MR-conditional (per ASTM F2052-15), and may be used during MR imaging for static magnetic fields of 3.0 T or less.
Device Description
The Essex MR Conditional CGA 870 pressure regulator is designed to be installed on a medical CGA 870 post valve cylinder, regulate high pressure oxygen from 500 to 2,000 psig nominal, deliver a specific amount of oxygen to an attached flow selector, and be ignition resistant.
The device consists of:
- A yoke style inlet fitting per CGA 870.
- A pressure regulator section is to reduce the pressure from 500-2,000 psig to 50 psig nominal.
- A flow selector valve to control the flow at the regulated pressure between 0 and 25 L/min.
- Made of materials which meet the MR Conditional requirements of ASTM F2052-15.
This is identical to our Class I, exempt model CGA 870 except for different materials to allow for the device to meet the ASTM F2052-15 - Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment.
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K Number
K161472Device Name
Walk-O2-Bout
Manufacturer
ESSEX INDUSTRIES, INC.
Date Cleared
2016-11-18
(175 days)
Product Code
ECX
Regulation Number
868.2700Why did this record match?
Applicant Name (Manufacturer) :
ESSEX INDUSTRIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Walk-O2-Bout® is an integrated portable oxygen delivery system intended to provide supplemental oxygen to pediatrics and adults in hospital, sub-acute care, and pre-hospital / ground transport settings. It is offered in models that are MR-conditional (per ASTM F2052-15), and intended for use during MR imaging for static magnetic fields of 3.0 T or less. Compressed gas cylinders in service or in storage shall be stabilized or otherwise secured to prevent falling and rolling.
Device Description
The Walk-O2-Bout® regulator is designed to be installed on a medical grade aluminum cylinder having 0.750-16 UNF-2B threads; regulate high pressure oxygen from 300-2000 psig nominal; deliver a prescribed amount of oxygen; and be ignition fault resistant. The device consists of: A threaded fill fitting per CGA 540. It shall allow the regulator installed on a cylinder to be refilled to its service pressure. It also allows for the pulling of a vacuum on the system. A pressure regulator section to reduce the pressure from 300-2000 psig to 50 psig nominal. Options of flow selector valves to control the flow between 0 and 25 L/min, at the regulated pressure. A vinyl dipped handle for ease of carrying. A DISS 1240 check valve to deliver 50 psig of oxygen high flow rates of oxygen to ventilators. There are several models offered. In all cases the basic pressure regulator is identical for all models. The models are offered with the following options: Flow rate range of 0 4 L/min (Pediatric), 0 15 L/min and 0 25 L/min (adult) Check Valve Swivel or Fixed Barb Fitting Handle style MR Conditional.
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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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K Number
K113767Device Name
MOUNTED MEDICAL OXYGEN SYSTEM
Manufacturer
ESSEX INDUSTRIES, INC.
Date Cleared
2012-06-29
(191 days)
Product Code
BYJ
Regulation Number
868.5655Why did this record match?
Applicant Name (Manufacturer) :
ESSEX INDUSTRIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MMOS is intended to convert liquid oxygen to gaseous oxygen for delivery to a patient and for delivery to rescue personnel to supplement environmental oxygen at high altitudes while mounted in rescue vehicles, e.g. HH-60 and HC-130 Guardian Angel (GA) rescue vehicles, at one-half (0.5) to fifteen (15) liters per minute (LPM) and fifty (50) pounds per square inch gauge (psig).
Device Description
The MMOS, when filled with liquid oxygen, is used to provide medical treatment to injured isolated personnel and to supplement environmental oxygen during high altitude and parachuting operations. The MMOS is primarily employed on board the HH-60, HC-130, and Guardian Angel (GA) rescue Vehicle to treat 1-2 patients for durations of 4-8 hours. The MMOS contains a thermally insulated container of liquid oxygen (LOX) that is intended to supplement gases to be inhaled by a patient. The MMOS supports medical devices provided by the user including masks, cannulas, and Bag Valve Mask (BVM) being attached to the flow control patient outlets. An empty portable liquid oxygen unit is a device, while the oxygen contained therein is a drug. The MMOS is portable. The handle on top of the housing, as well as the handles on the left and right side of the front-angled user interface, make the MMOS portable. The MMOS can be carried onboard, tied down, transported and operationally perform on various aircraft and ground vehicles. The MMOS 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. After connecting a tube assembly connector of a mask, cannula, and Bag Valve Mask (BVM) to an outlet port, masks, cannulas, and BVMs or other similar medical device (none of these devices is included in the MMOS) the patient can inhale the gaseous oxygen.
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K Number
K101272Device Name
MASS OXYGEN DISTRIBUTION SYSTEM (MODS) MODEL 10C-0061-3
Manufacturer
ESSEX INDUSTRIES, INC.
Date Cleared
2010-08-20
(106 days)
Product Code
BYJ
Regulation Number
868.5655Why did this record match?
Applicant Name (Manufacturer) :
ESSEX INDUSTRIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MODS is intended to convert liquid oxygen to gaseous oxygen (99.9% based on medical grade liquid oxygen) for delivery to a patient at one-half (0.5) to fifteen (15) LPM and fifty (50) psig.
Device Description
The MODS has a portable, thermally insulated container of liquid oxygen (LOX) that is intended to supplement gases to be inhaled by a patient, and is accompanied by tubing intended for connection to an oxygen mask.
The MODS is portable. The MODS houses the thermally insulated stainless steel container, which stores liquid oxygen, and is set on casters while the accompanying unit, the patient distribution kit, is encased with a handle. The MODS converts liquid oxygen (99.9% pure) from the insulated container through a heat exchanger into gaseous oxygen and finally the gaseous oxygen is distributed through the tubing in the accompanying interconnect hose or hose reel assembly and ultimately through the tubing in the accompanying patient distribution kit. After connecting the tube end to an oxygen mask, cannula, simulator ventilator, or other similar medical device (none of these devices is included in the MODS) the patient can inhale the gaseous oxygen.
The accompanying patient distribution kit has ten outlet ports that are capable of delivering oxygen to a maximum of ten patients. Multiple patient distribution kits can be used to deliver oxygen to more than patients.
The MODS has the capacity to store seventy-five (75) liters of LOX and convert it to a gaseous state. It can be filled using a fill harness and current commercially available LOX storage/filling systems such as a variable gas/liquid (VGL) cylinder. When using the MODS with external LOX cylinders, the system will run indefinitely under normal operating conditions (indoors at room temperature) as long as the LOX cylinders are rotated between each of two MODS external hookup ports. When filled with LOX, the MODS provides an uninterrupted supply of oxygen for delivery to patients at a maximum system flow rate of four hundred fifty (450) liters per minute (LPM) and, when connected to a patient distribution kit, at an individual patient flow rate of one-half (0.5) to fifteen (15) LPM. The nominal operating system pressure of the MODS is two hundred (200) psig and, when connected to a patient distribution kit, the individual hose pressure is fifty (50) psig.
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