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510(k) Data Aggregation
K Number
K072011Device Name
COPD LIQUID OXYGEN PORTABLE, MODEL 300P
Manufacturer
COPD PARTNERS, INC.
Date Cleared
2007-10-18
(87 days)
Product Code
BYJ
Regulation Number
868.5655Why did this record match?
Applicant Name (Manufacturer) :
COPD PARTNERS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The COPD Partners Model 300P Liquid Oxygen Portable will provide a source of supplemental oxygen for ambulatory home healthcare patients, by vaporizing medical grade liquid oxygen, and then dispensing it to the patient via an integral electronic conserving device. The Model 300P Liquid Oxygen Portable is neither a life-sustaining nor life-supporting device.
Device Description
The COPD Partners' Model 300P is a small, lightweight, liquid oxygen portable unit. The unit consists of a vacuum-insulated cryogenic Dewar, an economizer regulator, electronic printed circuit board (PCB), an oxygen conserving system, and a protective case.
The Dewar has a capacity and capability to store 0.33 liters of liquid oxygen. Dependant on the flow selection setting, the control system either delivers the oxygen to the conserving device or delivers a 2 LPM continuous flow directly to the oxygen outlet. The continuous flow setting is labeled CF on the flow method selector. The conserving device has an equivalent setting for 1, 2, 3, 4, and 5 LPM prescriptions. At the various conserving device settings, the outlet oxygen gas is delivered in quick pulses beginning at the start of inhalation.
The device also has a provision to track the patient's breath rate and in the event of an increase in breath rate, will deliver an increased volume of oxygen. There are two levels of increased volume, one at 4 breath per minute (BPM) over normal breath rate and another at 8 BPM over normal breath rate. The device delivers an extra 16 cc at each of these two thresholds. The COPD Partners Model 300P is transfilled from a commercially available medical grade liquid oxygen source.
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K Number
K071461Device Name
MODEL 300D HOME OXYGEN LIQUEFIER
Manufacturer
COPD PARTNERS, INC.
Date Cleared
2007-08-21
(88 days)
Product Code
CAW, BYJ
Regulation Number
868.5440Why did this record match?
Applicant Name (Manufacturer) :
COPD PARTNERS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Model 300D Home Oxygen Liquefier is intended for use in liquefying oxygen supplied by a concentrator equipped with an oxygen sensing device. The concentrator used with the home oxygen liquefier should generate >90% oxygen purity nominally, and alert the user if this purity drops to unacceptable levels. This liquid oxygen is intended for use with the liquid portable products rated for 93% oxygen such as the Caire Spirit 300 HAS product. This system and the associated portable are intended for use with 93% (+3%) oxygen.
It may be used in the home or institution. It is intended to be used with both pediatric and adult patients. It is not intended to be a life sustaining or life supporting device. The device has no contraindications.
Device Description
The COPD Partners' model 300D is a home oxygen liquefaction device. The product is intended to connect to an oxygen concentrator that is equipped with an oxygen sensing device to assure adequate levels of oxygen purity. The model 300D then splits the gas source from the concentrator, giving the patient their desired level of gas flow and uses the remaining flow for the liquefaction portion of the unit. The liquefaction portion of the device consists of desiccants, a boost pump compressor, a high pressure compressor, a series of heat exchangers, a dual stage cascade refrigeration pre-cooler, a microcontroller based controller system, and a Dewar with a Joule Thompson (JT) valve. This device pressurizes the gas, cools it, and then expands the gas through the JT valve, where a portion of the gas will convert to liquid oxygen will be used to fill a liquid oxygen portable such as the COPD Partners' Model 300P. The device indicates the level of liquid in the Dewar and has a control system to display this information to the user. In addition, it automatically turns on to maintain a desired level of liquid in the Dewar.
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