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510(k) Data Aggregation
K Number
K051583Device Name
TIARA SNAPP X SOFT NASAL ACCESSORY FOR POSITIVE PRESSURE, MODELS TMS-3020, TMS-3030, TMS- 3040, TMS-3050
Manufacturer
TIARA MEDICAL SYSTEMS, INC.
Date Cleared
2005-11-04
(142 days)
Product Code
BZD
Regulation Number
868.5905Why did this record match?
Applicant Name (Manufacturer) :
TIARA MEDICAL SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Tiara Medical Systems SNAPP-X is intended to be used with continuous positive airway pressure devices (CPAP), operating at or above 3 cmH20 for the treatment of obstructive sleep apnea. The SNAPP-X is intended for single patient use and can be used in the home or in a hospital/institutional environment. The SNAPP-X is to be used on adult patients (>30Kg) for whom continuous positive airway pressure has been prescribed
Device Description
The Tiara Medical Systems SNAPP™ -X Soft Nasal Accessory for Positive Pressure is a nasal cannula with inserts intended to be used with positive airway pressure devices such as CPAP (Continuous Positive Airway Pressure). It provides a seal such that positive pressure from a positive pressure source is directed into the patient's nose. It is held in place with an adjustable headgear. It may be cleaned with mild detergent such as Ivory® dishwasher liquid and water. The cleaning process does not require disassembly.
The device consists of latex-free silicone air delivery tubes connecting a polycarbonate Wye adapter / swivel with a latex-free silicone soft, resilient nasal inserts which form a seal with the nostrils.
The device connects to a conventional air delivery hose between itself and the positive airway pressure source via a standard 22 mm polycarbonate fitting on the combination Wye adapter / swivel. The built in vent slots are molded into the underside of the nasal insert body to direct air away from the patient's face and chest, and eliminate the need for a separate exhalation device. The vent slots may be visually checked for obstruction prior to use.
The SNAPP-X Headgear is available in multiple sizes to fit a broad range of facial structures, and attaches to the SNAPP-X via slots molded into the nasal insert body.
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K Number
K043382Device Name
TMS FULL ADVANTAGE FULL FACE MASK, MODELS TMS-2820, TMS-2830, TMS-2840
Manufacturer
TIARA MEDICAL SYSTEMS, INC.
Date Cleared
2005-01-19
(41 days)
Product Code
BZD
Regulation Number
868.5905Why did this record match?
Applicant Name (Manufacturer) :
TIARA MEDICAL SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Tiara Medical Systems FULL ADVANTAGE™ Full Face Mask is intended to be used with positive airway pressure devices such as CPAP (Continuous Positive Airway Pressure) for the treatment of adult obstructive sleep apnea.
Device Description
The Tiara Medical Systems Full Advantage™ Full Face Mask is an externally placed mask covering the nose and mouth of the patient. It provides a seal such that positive pressure from a positive pressure source is directed to the patient's nose and mouth when either or both are open. It is held in place with an adjustable headgear. It may be cleaned with mild soap and water. The cleaning process requires limited disassembly.
The mask consists of a molded multiple sized polycarbonate shell with a soft, resilient silicone skincontacting cushion seal which conforms to the patient's facial features. A silicone forehead pad attaches to a polycarbonate frame and is adjustable to suit patient comfort.
The mask connects to a conventional air delivery hose between the mask and the positive airway pressure source via a standard 22 mm polycarbonate elbow/swivel/valve assembly. The elbow/swivel/valve assembly attaches to the front of the mask with a polyethylene split "c" clip. The built in vent ports are located on the elbow/swivel/valve assembly to provide a continuous air leak to prevent rebreathing of deadspace CO2, direct air away from the patient's face and chest, and eliminate the need for a separate exhalation device. The vent ports also allow the patient to exhale normally and do not interfere with the other performance requirements of the vent ports may be visually checked for obstruction prior to use. The elbow/swivel/valve assembly also includes a built in Anti-Asphyxia Valve which allows the patient to continue to breathe fresh air in the event of positive air pressure device failure or output deterioration, or delivery hose kinking/obstruction.
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K Number
K034053Device Name
TMS SNAPP SOFT NASAL ACCESSORY FOR POSITIVE PRESSURE, MODELS TMS-3020, TMS-3030 & TMS-3040
Manufacturer
TIARA MEDICAL SYSTEMS, INC.
Date Cleared
2004-06-24
(177 days)
Product Code
BZD
Regulation Number
868.5905Why did this record match?
Applicant Name (Manufacturer) :
TIARA MEDICAL SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Tiara Medical Systems SNAPP is intended to be used with continuous positive airway pressure devices (CPAP), operating at or above 3 cmH20 for the treatment of obstructive sleep apnea. The SNAPP is intended for single patient use and can be used in the home or in a hospital/institutional environment. The SNAPP is to be used on adult patients (>30Kg) for whom continuous positive airway pressure has been prescribed.
Device Description
The Tiara Medical Systems SNAPP Soft Nasal Accessory for Positive Pressure is a nasal cannula with inserts intended to be used with positive anway pressure devices such as CPAP (Continuous Possure). It provides a seal such that positive pressure from a positive pressure source is directed into the patient's nose. It is held in place with an adjustable headgear. It may be cleaned with mild soap and water. The cleaning process does not require disassembly.
The device consists of latex-free silicone air delivery tubes connecting a polycarbonate Wye adapter / swivel with a latex-free silicone soft, resilient nasal inserts which form a seal with the nostrils.
The device connects to a conventional air delivery hose between itself and the positive airway pressure source via a standard 22 mm polycarbonate fitting on the combination Wye adapter / swivel. The built in vent slots are molded into the underside of the nasal insert body to direct air away from the patient's face and chest, and eliminate the need for a separate exhalation device. The vent slots may be visually checked for obstruction prior to use. The SNAPP Headgear is available in three sizes to fit a broad range of facial structures, and attaches to the SNAPP via slots molded into the nasal insert body.
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K Number
K031935Device Name
TIARA MEDICAL SYSTEMS ADVANTAGE II NASAL MASK, MODELS TMS-2520 AND TMS-2530
Manufacturer
TIARA MEDICAL SYSTEMS, INC.
Date Cleared
2004-03-03
(254 days)
Product Code
BZD
Regulation Number
868.5905Why did this record match?
Applicant Name (Manufacturer) :
TIARA MEDICAL SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Tiara Medical Systems Advantage II Nasal Mask is intended to be used with continuous positive airway pressure devices (CPAP); operating at or above 3 cmH20 for the treatment of obstructive sleep apnea. The mask is intended for single patient use and can be used in the home or in a hospital/institutional environment. The mask is to be used on adult patients (>30Kg) for whom continuous positive airway pressure has been prescribed.
Device Description
The Tiara Medical Systems Advantage II™ Nasal Mask is an externally placed mask covering the nose such that positive pressure from a positive pressure source is directed of the patient's nose. It is held in place with an adjustable headgear. It may be cleaned with mild soap and water. The cleaning process requires limited disassembly.
The mask consists of a molded polycarbonate shell with a soft, resilient silicone skin-contacting rille mask conforms to the patient's facial features. A silicone forehead cushion is available for added comfort.
The mask connects to a conventional air delivery hose between the mask and the positive airway pressure source the mask with a polyethylene split "c" ring. The built in vent slots (2) are located attacres to the from of the make with a perfect's face and chest, and eliminate the need for a separate exhalation device. The vent slots may be visually checked for obstruction prior to use.
Canadation access is available in a variety of sizes to fit a broad range of facial structures, and attaches to the mask via slots contained within the shell.
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K Number
K012207Device Name
ADVANTAGE NASAL MASK, SMALL, ADVANTAGE NASAL MASK. REGULAR, MODELS TMS-2520, TMS 2530
Manufacturer
TIARA MEDICAL SYSTEMS, INC.
Date Cleared
2001-07-23
(7 days)
Product Code
BZD
Regulation Number
868.5905Why did this record match?
Applicant Name (Manufacturer) :
TIARA MEDICAL SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Tiara Medical Systems Advantage™ Nasal Mask is intended to be used with positive airway pressure devices such as CPAP (Continuous Positive Airway Pressure), operating at or above 3 cmH2O for the treatment of adult obstructive sleep apnea.
Device Description
Not Found
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K Number
K992192Device Name
AIRPILOTMASK, MODEL TMS-900
Manufacturer
TIARA MEDICAL SYSTEMS, INC.
Date Cleared
2000-05-12
(318 days)
Product Code
BZD
Regulation Number
868.5905Why did this record match?
Applicant Name (Manufacturer) :
TIARA MEDICAL SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The TIARA MEDICAL SYSTEMS INC. AirPilotMask ™ Nasal Mask is a non-sterile, clean, single patient reusable mask intended to be used with CPAP (continuous airway pressure) devices for the treatment of adult obstructive sleep apnea.
Device Description
TIARA MEDICAL SYSTEMS INC. AirPilotMask™ Nasal Mask
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K Number
K964092Device Name
TMS COMFORT SERIES NASAL CPAP MASK
Manufacturer
TIARA MEDICAL SYSTEMS, INC.
Date Cleared
1997-07-31
(293 days)
Product Code
BZD
Regulation Number
868.5905Why did this record match?
Applicant Name (Manufacturer) :
TIARA MEDICAL SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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