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510(k) Data Aggregation
K Number
K232516Device Name
Sentec Digital Monitoring System (SDMS) tCOM+
Manufacturer
Sentec AG
Date Cleared
2024-05-17
(273 days)
Product Code
LKD, DPZ, DQA, KLK, LPP
Regulation Number
868.2480Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Sentec Digital Monitoring System (SDMS) - consisting of monitors, sensors, cables, accessories and disposables for sensor application/maintenance and PC-based software - is indicated for non-invasive patient monitoring of oxygenation and ventilation.
The Sentec Digital Monitoring System is for prescription use only. Devices are non-sterile and non-invasive.
The monitor is not in direct contact with the patient during monitoring. The V-Sign™ Sensor 2, the OxiVenT™ Sensor. the Ear Clip, the Multi-Site Attachment Rings, the Non-Adhesive Wrap, the Staysite™ Adhesive and the Contact Gel are in contact with the intact skin of the patient during monitoring.
Device Description
Sentec's Digital Monitoring System is intended for the continuous and noninvasive monitoring of cutaneous carbon dioxide partial pressure (PCO2), cutaneous oxygen partial pressure (PC2), oxygen saturation (SpO2) and pulse rate (PR) in adult and pediatric patients as well as for PCO2 and PO2 monitoring in neonatal patients.
The tCOM+ (REF 103164) is a portable, lightweight, stand-alone monitor with a convenient carrying handle and with an integrated calibration and storage facility for the V-Sign™ Sensor 2 or OxiVenT™ Sensor, respectively. It provides continuous and noninvasive PCO2, SpO2 and PR monitoring if used with a V-Sign™ Sensor 2 or PCO2, PO2, SpO2 and PR monitoring if used with a OxiVenT™ Sensor.
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K Number
K161179Device Name
Intelli-Ox
Manufacturer
AIR LIQUIDE HEALTHCARE AMERICA CORPORATION
Date Cleared
2017-04-13
(352 days)
Product Code
ECX
Regulation Number
868.2700Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Intelli-OX is an integrated portable oxygen delivery system intended to provide supplemental oxygen to adults. The device is MR Conditional and suitable for use during MR imaging for MRI systems up to 3.0 Tesla. When administered by properly trained personnel for oxygen deficiency and resuscitation, the Intelli-Ox is for all other medical applications, the device is Rx only.
Device Description
The Intelli-OX portable oxygen delivery system that supplies Oxygen USP using a device comprised of an integrated valve-regulator, flow meter and medical aluminum cylinder with handle and shroud all integrated into a single unit. A range of user-selectable flow setting is available with the user being able to control the flow rate, including low flows that may be clinically appropriate for certain classes of patients. An additional DISS-1240 connection provides standard high flow oxygen delivery. When administered by properly trained personnel for oxygen deficiency and resuscitation. Intelli-OX is for emergency use only. For all other medical applications, the device is Rx only. Key specifications include hose barb connection, protective shroud, carrying handle, easy to read content gauge, indexed flow meter, and integrated valve-regulator. This design allows medical personnel the ability to provide patient care and treatment sooner without delays caused by the need to mount a conventional regulator. The device is MR Conditional and suitable for use during MR imaging for MRI systems up to 3.0 Tesla.
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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?
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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?
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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
K080243Device Name
PORTABLE OXYGEN UNIT SCA900
Manufacturer
SAN CHEONG CO. LTD.
Date Cleared
2009-04-07
(432 days)
Product Code
CAN, ECX, KGA
Regulation Number
868.2700Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Portable Oxygen Unit SCA900 is an integrated portable oxygen delivery system intended to provide supplemental oxygen to adults; a pressure regulator, flow meter and oxygen cylinder fully integrated into single unit. For emergency use only when administered by properly trained personnel for oxygen deficiency and resuscitation. For all other medical applications, Rx only. Compressed gas cylinders in service or in storage shall be stabilized or otherwise secured to prevent falling and rolling.
Device Description
The Portable Oxygen Unit SCA900 is a portable oxygen delivery system, consisting of a fully integrated cylinder, valve, regulator, nasal cannula and mask. The oxygen is delivered through the mask or nasal cannula with a range of user-selectable flow settings. This unit is suitable for use in all healthcare settings. including hospital and home healthcare.
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K Number
K063354Device Name
LINDE INTEGRATED VALVE (LIV)
Manufacturer
LINDE GAS THERAPEUTICS
Date Cleared
2007-04-17
(162 days)
Product Code
ECX
Regulation Number
868.2700Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The LIV is an integrated portable oxygen delivery system intended to provide supplemental oxygen to pediatrics and adults. The device is MR-conditional (per ASTM standard 2503-05), and intended for use during MR imaging for MRI systems up to 3.0T. For emergency use only when administered by properly trained personnel for oxygen deficiency and resuscitation. For all other medical applications, Rx only. Compressed gas cylinders in service or in storage shall! be rah Uized or otherwise secured to prevent falling and rolling.
Device Description
The Linde Integrated Valve™ ("LIV") is a portable oxyqen delivery system, consisting of a fully integrated cylinder, valve, requlator, flow meter, and shock-absorbing quard. A range of user-selectable flow settings is available, including low flows that may be clinically appropriate for certain classes of patients. An additional DISS-1240 connection provides standard 50psig oxygen delivery, while an optional bed hanger allows the LIV to be readily attached to a bed. The LIV is suitable for use in all healthcare settings, including, but not limited to, hospital, outpatient, imaging center, ambulatory, and home healthcare.
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K Number
K060265Device Name
REMCORE REMOTE CONTROLLED OXYGEN REGULATOR
Manufacturer
REMCORE, INC.
Date Cleared
2006-10-25
(266 days)
Product Code
CAN
Regulation Number
868.2700Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Remcore Remote Control Oxygen Delivery system is an adjunct to the use of supplemental oxygen prescribed by a physician for a patient whose lung disease limits his or her ability to adequately supply the body with oxygen. The amount of supplemental oxygen needed to continuously provide the oxygen saturation prescribed will vary with different degrees of exertion. Current oxygen delivery systems do not allow a patient to alter the flow rate of oxygen when the patient is not next to the oxygen source. The Remore Remote Control Oxygen Delivery System allows a patient to change the flow rate, as prescribed by the physician, in accordance with the activity of the patient. For example, a patient might require 2 liters/minute of supplemental oxygen at rest, but 5 liters/minute to climb the stairs. The Remcore system will allow the patient sitting downstairs to remotely increase the oxygen flow rate to 5 liters/minute, regardless of where in the house the oxygen tank or concentrator is located, and after arriving upstairs to remotely return the oxygen flow rate to 2 liters/minute.
Device Description
Remcore Remote Control Oxygen Delivery System
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K Number
K061785Device Name
CYL-FIL OXYGEN SYSTEM
Manufacturer
RESPONSIVE RESPIRATORY INC.
Date Cleared
2006-09-07
(76 days)
Product Code
CAN, CLA, ECX
Regulation Number
868.2700Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Cyl-Fil Oxygen System is intended to provide supplemental oxygen by prescription only. Cyl-Fil is a two component system. The first component consists of a high pressure regulator that delivers USP oxygen from a supply cylinder having two pressure settings. The second component is a light-weight portable, high pressure cylinder that is refilled by use of the Cyl-Fil pressure regulator.
The intended patient population is to supply, by prescription only, supplemental oxygen to patients requiring additional oxygen.
Device Description
The Responsive Respiratory Cyl-Fil Oxygen System is a two component system. The first component is a high pressure regulator that delivers USP Grade oxygen at two pressure settings. The second component is a lightweight, portable high pressure cylinder with an oxygen specific post valve (similar to CGA-870 with an additional pin/hole location unique to the Cyl-Fil system) that incorporates a residual pressure retention device to insure that the USP oxygen is always retained in the cylinder. The portable cylinder is prepared and filled with USP oxygen according to industry and FDA requirements.
A supply cylinder supplies USP oxygen to the inlet connection (standard CGA-540) of the Cyl-Fil regulator. The Cyl-Fil regulator pressure setting delivers USP oxygen to the Cyl-Fil portable cylinder at a pressure and rate that does not exceed the safety rating of the cylinder, according to the cylinder manufacturer's specifications. The second Cyl-Fil regulator pressure setting delivers USP oxygen to an auxiliary outlet connection (CGA-1240) for continuous oxygen therapy support in the home.
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K Number
K033897Device Name
MEDICYL-E-LITE PORTABLE OXYGEN DELIVERY SYSTEM
Manufacturer
AGA-LINDE HEALTH CARE
Date Cleared
2004-07-19
(216 days)
Product Code
ECX
Regulation Number
868.2700Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MEDICYL-E-Lite is an integrated portable oxygen delivery system intended to provide supplemental oxygen to adults. The device is MRI safe, MRIcompatible, and intended for use during MR imaging for MRI systems up to 3.0T.
For emergency use only when administered by properly trained personnel for oxygen deficiency and resuscitation. For all other medical applications, Rx only. Compressed gas cylinders in service or in storage shall be stabilized or otherwise secured to prevent falling and rolling.
Device Description
The MEDICYL-E-Lite is an integrated portable oxygen delivery system intended to provide supplemental oxygen to adults. The device is MRI safe, MRI-compatible, and intended for use during MR imaging for MRI systems up to 3.0T. For emergency use only when administered by properly trained personnel for oxygen deficiency and resuscitation. For all other medical applications, Rx only. Compressed gas cylinders in service or in storage shall be stabilized or otherwise secured to prevent falling and rolling.
The intearated system includes an aluminum cylinder, valve, requlator and flow meter. The device offers low flow settings that may be clinically appropriate for certain classes of patients.
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