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510(k) Data Aggregation
K Number
K090804Device Name
NASAL AIRE II PEDIATRIC, MODEL 5 SIZES, MODEL TBD
Manufacturer
INNOMED TECHNOLOGIES INC./RESPCARE INC.
Date Cleared
2009-11-05
(225 days)
Product Code
BZD
Regulation Number
868.5905Why did this record match?
Applicant Name (Manufacturer) :
INNOMED TECHNOLOGIES INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Nasal-Aire II Pediatric interface is an accessory to positive pressure ventilation devices (i.e. CPAP, Bi-Level) for both adult and pediatric patients aged seven and older or weighing more than 40 lbs, in the hospital, clinic or home environments.
The Nasal-Aire II Pediatric is intended for single-patient re-use in the home environment and multiple-patient re-use in the hospital / institutional environment.
Device Description
The Nasal-Aire II Pediatric has been modified from the Nasal-Aire II to meet the requirements of the pediatric population and adults requiring smaller sizes to achieve the proper fit and comfort. The Nasal-Aire II Pediatric provides therapy through the nose only.
The Nasal-Aire II Pediatric interface is an accessory to positive pressure ventilation devices (i.e. CPAP, Bi-Level) for both adult and pediatric patients aged seven and older or weighing more than 40 lbs, in hospital, clinic, or home environments.
For homecare applications, the Nasal-Aire II Pediatric may be reused multiple times by a single patient. For institutional applications (i.e. sleep lab, other clinical settings), the interface may be reused multiple times by multiple patients.
The Nasal-Aire II Pediatric interface has a soft nasal cannula to form a seal with the nasal openings. The nasal cannula has two nasal inserts and has integrated exhalation ports. The interface also has tubing, connectors to attach the tubing to the nasal cannula, and a swivel coupling that allows the interface to connect to the ventilation device. Headgear is attached to the device to secure the interface on the patient.
There are five nasal cannula sizes available, ranging from A (largest) to E (smallest).
The device is available by prescription only.
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K Number
K062019Device Name
RESPCARE HYBRID NE FACE MASK, MODEL TBD,; DISPOSABLE, MODEL TBD
Manufacturer
INNOMED TECHNOLOGIES INC./RESPCARE INC.
Date Cleared
2006-08-17
(31 days)
Product Code
CBK
Regulation Number
868.5895Why did this record match?
Applicant Name (Manufacturer) :
INNOMED TECHNOLOGIES INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Hybrid NE Mask is intended to provide a patient interface for application of noninvasive ventilation. The mask is to be used as an accessory to ventilators that have adequate alarms and safety systems for ventilator failure, and which are intended to administer positive pressure ventilation. The mask will be offered in a disposable version and a multiuse version. It is intended for use on adult patients (>30 kg), who are appropriate candidates for noninvasive ventilation.
(Applies to the standard version):
For homecare applications, the Hybrid NE Mask may be reused multiple times by a single patient. For institutional applications (i.e. hospital or other clinical settings), this interface may be reused multiple times by multiple patients.
(Applies to the Disposable version): The RespCare Hybrid NE Mask Disposable is a single patient, single use interface.
Device Description
A specialized interface for Non-Invasive Ventilation. It will be modeled after the RespCare Face Mask (K052227), with intentional exhalation features removed for use with ventilators equipped with an active safety valve.
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K Number
K050171Device Name
IT NASAL MASK
Manufacturer
INNOMED TECHNOLOGIES
Date Cleared
2005-05-04
(98 days)
Product Code
BZD
Regulation Number
868.5905Why did this record match?
Applicant Name (Manufacturer) :
INNOMED TECHNOLOGIES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The InnoMed Technologies IT Nasal Mask is intended to be used as a patient interface for currently-marketed CPAP and Bi-Level positive-pressure ventilation devices capable of generating pressures up to 20cm H₂O. It is indicated for use in non-critical care applications such as treatment of adult obstructive sleep apnea and ventilatory support during respiratory insufficiency.
The InnoMed Technologies IT Nasal Mask is available by prescription, and is intended for single patient use only for adult patients (>30kg) in home or hospital settings.
Device Description
The IT Nasal mask consists of a polycarbonate faceplate shaped to fit around the patient's nose, and a silicon cushion covering the edge of the faceplate where the mask makes contact with the patient's face. At the front of the mask's faceplate is a 90-degree elbow attached so as to allow it to rotate 360 degrees relative to the faceplate.
The other end of the elbow is configured as a standard female 22mm fitting for the attachment of a separate exhalation port/swivel that is supplied with each IT Nasal Mask. This exhalation port is configured so as to sufficiently exhaust exhaled air from the patient at a proper flow rate. The other end of the exhalation port/swivel allows connection to a CPAP or bi-level positive pressure ventilator's flexible breathing circuit tubing.
The IT Nasal mask is available in seven different sizes in order to accommodate a broad range of facial feature variations.
The IT Nasal Mask is secured to the patient by a single-piece nylon cloth headset. The headset has four straps which allow the mask to be adjusted for proper fit and patient comfort, and provide for quick removal of the mask.
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K Number
K031896Device Name
NASAL-AIR CRITICAL CARE
Manufacturer
INNOMED TECHNOLOGIES
Date Cleared
2004-01-14
(209 days)
Product Code
MNS, BZD
Regulation Number
868.5895Why did this record match?
Applicant Name (Manufacturer) :
INNOMED TECHNOLOGIES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Nasal-Aire Critical Care ventilator interface is intended for use with a CPAP or Bi-Level device to provide noninvasive ventilation in adult patients for the treatment of respiratory insufficiencies or obstructive sleep apnea. This single use disposable interface is intended for hospital settings.
Device Description
Nasal-Aire Criticial Care is ventilator interface accessory intended for use with a CPAP or Bi-Level device to provide noninvasive ventilation in adult patients for the treatment of respiratory insufficiencies or obstructive sleep apnea. This single use disposable interface is intended for hospital settings.
Nasal-Aire Critical Care consists of a soft nosepiece with two exhaust ports and two soft nasal cannula for fitting into the nasal openings. Connected on each side of the nosepiece is a length of tubing. The two lengths of tubing are joined at the opposite ends by a "Y"-shaped coupling, forming a loop with the nosepiece at one end and the "Y" coupling at the other. At the base of the "Y" coupling is a port for connection of the Nasal-Aire Critical Care to a positive pressure ventilation device. The Nasal-Aire Critical Care is compatible with any positive pressure ventilator containing a 22mm connection. Nasal-Aire Critical Care will be offered in various sizes designed for a comfortable and compliant fit for a wide variety of nare sizes.
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K Number
K022465Device Name
MODIFICATION TO NASAL-AIRE
Manufacturer
INNOMED TECHNOLOGIES
Date Cleared
2003-03-21
(238 days)
Product Code
BZD
Regulation Number
868.5905Why did this record match?
Applicant Name (Manufacturer) :
INNOMED TECHNOLOGIES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Nasal-Aire //™ Interface is an accessory to positive pressure ventilation devices for patients suffering from Obstructive Sleep Apnea requiring positive pressure breathing therapy (i.e. CPAP, BiLevel)
Device Description
Nasal-Aire IITM Accessory to a Positive Pressure Ventilation Device
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