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510(k) Data Aggregation
K Number
K242667Device Name
AeroChamber2go Anti-Static Valved Holding Chamber
Manufacturer
Trudell Medical International
Date Cleared
2025-01-15
(132 days)
Product Code
NVP
Regulation Number
868.5630Why did this record match?
Product Code :
NVP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This product is intended to be used by patients (5+ years) who are under the care or treatment of a physician or licensed healthcare professional. The device is intended to be used by these patients to administer aerosolized medication from most pressurized Metered Dose Inhalers. It is a single patient, multiple use device intended for home use.
Device Description
The AeroChamber2go* Anti-Static Valved Holding Chamber (VHC) is a portable holding chamber intended to be used by patients (5+ years) who are under the care or treatment of a physician or licensed healthcare professional. The device is intended to be used by these patients to administer aerosolized medication from most pressurized Metered Dose Inhalers. It is a single patient, multiple use device intended for home use. This device is not used with a specific druq nor is it distributed with such drugs.
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K Number
K210558Device Name
LiteAire Basic Dual-Valved, Collapsible MDI Holding Chamber
Manufacturer
Thayer Medical Corporation
Date Cleared
2022-04-01
(400 days)
Product Code
NVP
Regulation Number
868.5630Why did this record match?
Product Code :
NVP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The LiteAire is a collapsible, disposable dual-valved holding chamber designed to aid in the delivery of aerosolized medications delivered via a pressurized metered dose inhaler (MDI).
The LiteAire features a standard port designed for compatibility with standard MDI mouthpieces. It is a non-sterile device for single-patient use.
The LiteAire is intended to be used by adults, adolescents and children ages 5 and up who are able to use a holding chamber without the aid of a mask and who are under the care or treatment of a physician or licensed healtheare professional.
Device Description
The LiteAire® BASIC Dual Valved, Collapsible MDI Holding Chamber (also referred to as the LiteAire® BASIC) and the modified LiteAire® Dual Valved, Collapsible MDI Holding Chamber (also referred to as the modified LiteAire®), are intended for use in the inhalation of medications delivered via a pressurized metered dose inhaler (pMDI). The subject devices feature a universal port designed for compatibility with most MDI medications. The subject devices are intended for use by a single patient and, when properly cared for, are reusable for up to one week. The devices consist of a collapsible paperboard housing and two one-way valves to control the direction of air flow when the patient inhales and exhales through the devices are popped-up by the user prior to use by pressing against the sides of the devices, can be collapsed flat between uses, and are anti-static. The intended environments of use include the home, hospitals and clinics. Note that the only differences between the modified LiteAire® and LiteAire® BASIC configurations is the removal of the window.
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K Number
K181649Device Name
AeroChamber Plus* Flow-Vu* Anti-Static Valved Holding Chamber (VHC)
Manufacturer
Trudell Medical International
Date Cleared
2019-01-11
(203 days)
Product Code
NVP
Regulation Number
868.5630Why did this record match?
Product Code :
NVP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The AeroChamber Plus* Flow-Vu* Anti-Static Valved Holding Chamber is intended to be used by adult and pediatric patients who are under the care or treatment of a physician or licensed healthcare professional. The device is intended to be used by these patients to administer aerosolized medication from most pressurized Metered Dose Inhalers and Soft Mist Inhalers. The intended environments for use include the home. It is a single patient, multiple use device.
Device Description
The AeroChamber Plus* Flow-Vu* Anti-Static Valved Holding Chamber (VHC) is a holding chamber used for the administration of aerosolized medications. The AeroChamber Plus* Flow-Vu* Anti-Static VHC line of products is designed to be used with a broad range of FDA approved pressurized metered dose inhaler (pMDI) or soft mist inhaler (SMI) pharmaceutical formulations prescribed by a healthcare provider. It is a single patient, multi-use device intended to be used by patients who are under the care or treatment of a licensed health care professional. This device is not used with a specific drug nor is it distributed with such drugs.
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K Number
K160109Device Name
Thayer Medical LiteAire Dual-valved, Collapsible MDI Holding Chamber
Manufacturer
THAYER MEDICAL CORPORATION
Date Cleared
2017-05-19
(486 days)
Product Code
NVP
Regulation Number
868.5630Why did this record match?
Product Code :
NVP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The LiteAire is a collapsible, disposable dual-valved holding chamber designed to aid in the delivery of aerosolized medications delivered via a pressurized metered dose inhaler (MDI).
The LiteAire features a standard port designed for compatibility with standard MDI mouthpieces. It is a non-sterile device for single-patient use.
The LiteAire is intended to be used by adults, adolescents and children ages 5 and up who are able to use a holding chamber without the aid of a mask and who are under the care or treatment of a physician or licensed healthcare professional.
Device Description
The Thayer Medical LiteAire Dual-valved, Collapsible MDI Holding Chamber is intended for use in the inhalation of medications delivered via a pressurized metered dose inhaler (pMDI). The device consists of a collapsible paperboard housing and 2 one-way valves to control the direction of air flow when the patient inhales and exhales through the device. The LiteAire is not sterile, but clean and ready to use right out of the package. The LiteAire can be assembled by gently pushing in the edges of the device. The holding chamber can also be collapsed flat between uses and is anti-static.
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K Number
K143615Device Name
Antistatic Compact Space Chamber
Manufacturer
MEDICAL DEVELOPMENTS INTERNATIONAL LIMITED
Date Cleared
2016-01-26
(403 days)
Product Code
NVP
Regulation Number
868.5630Why did this record match?
Product Code :
NVP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The antistatic Compact Space Chamber is intended to be used by patients who are under the care or treatment of a licensed health care provider or physician. The device is intended to be used by these patients to administer aerosolized medication from most pressurized Metered Dose Inhalers, prescribed by a physician or health care professional. The device is intended for use in neonates, infants, children, adolescents and adults. The intended environments for use include home, hospitals and clinics.
Device Description
Antistatic Compact Space Chamber
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K Number
K140062Device Name
FSC ANTI-STATIC VALVED COLLAPSIBLE HOLDING CHAMBER
Manufacturer
FSC LABORATORIES, INC.
Date Cleared
2014-10-03
(266 days)
Product Code
NVP
Regulation Number
868.5630Why did this record match?
Product Code :
NVP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The FSC Anti-Static Valved Collapsible Holding Chamber is intended to be used by patients who are under the care or treatment of a licensed health care professional. The device is intended to be used by these patients to administer aerosolized medication from most pressurized Metered Dose Inhalers, (pMDIs).
Environment of use - Home, hospitals and clinics.
This product is intended for patients who can follow verbal instructions.
Device Description
The FSC Anti-Static Valved Collapsible Holding Chamber is intended for use in the inhalation of medications delivered via an MDI and for which the medication is to be delivered to the upper and lower respiratory system. The device consists of a collapsible housing and mouth piece and a one-way valve to prevent exhaling into the chamber.
The FSC Anti-Static Valved Holding Chamber is intended to inhale aerosolized drugs of approved MDIs from the following groups of active substances:
- · Corticosteroids (anti-inflammatory medications)
- · Anti-cholinergics and ß2-sympathomimetics (bronchodilator medications)
- · Non-steroidal chromones (DNCG)
It is a single patient, multi-use, non-sterile device.
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K Number
K122252Device Name
SPACE CHAMBER PLUS COMPACT SPACE CHAMBER PLUS
Manufacturer
MEDICAL DEVELOPMENTS INTERNATIONAL
Date Cleared
2013-11-13
(474 days)
Product Code
NVP
Regulation Number
868.5630Why did this record match?
Product Code :
NVP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Space Chamber Plus and Compact Space Chamber Plus are intended to be used by patients who are under the care or treatment of a licensed health care provider or physician. The devices are intended to be used by these patients to administer aerosolized medication from most pressurized Metered Dose Inhalers, prescribed by a physician or health care professional. The intended environments for use include home, hospitals and clinics.
Device Description
The Space Chamber Plus and Compact Space Chamber Plus are devices designed to assist patients with inhaling aerosolized medication dispensed through a Metered Dose Inhaler. The devices consist of a cylindrical chamber with an opening at each end. One opening is for the aerosol medication to be inserted, the other is tapered into a mouthpiece for inhalation. The mouthpiece can be used with or without a mask. The Compact Space Chamber Plus is a smaller version of the Space Chamber Plus that allows for easier storage and handling.
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K Number
K130598Device Name
INSPIRACHAMBER ANTI-STATIC VALVED HOLDING CHAMBER
Manufacturer
INSPIRX, INC.
Date Cleared
2013-06-05
(90 days)
Product Code
NVP
Regulation Number
868.5630Why did this record match?
Product Code :
NVP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The InspiraChamber® Anti-Static Valved Holding Chamber is intended to be used by patients who are under the care or treatment of a licensed health care professional. The device is intended to be used by these patients to administer aerosolized medication from most pressurized Metered Dose Inhalers, (pMDIs).
Environment of use - Home, hospitals and clinics where patients may require the use of a holding chamber with pMDIs.
The intended patient population is 3 years and older who have been prescribed pMDI medications.
Device Description
The InspiraChamber® is intended for use in the inhalation of medications delivered via an MDI and for which the medication is to be delivered to the upper and lower respiratory system. The device consists of a translucent housing and mouth piece or face mask and a one-way valve to prevent exhaling into the chamber.
The InspiraChamber® is intended to be used to inhale aerosolized drugs of approved MDIs from the following groups of active substances:
- · Corticosteroids (anti-inflammatory medications)
- · Anti-cholinergics and B2-sympathomimetics (bronchodilater medications)
- · Non-steroidal chromones (DNCG)
It is a single patient, multi-use, non-sterile device.
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K Number
K112010Device Name
AEROCHAMBER PLUS FLOW-VU ANTI-STATIC VALVED HOLDING CHAMBER (VHC)
Manufacturer
TRUDELL MEDICAL INTL.
Date Cleared
2012-07-11
(363 days)
Product Code
NVP
Regulation Number
868.5630Why did this record match?
Product Code :
NVP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K110293Device Name
OPTICHAMBER DIAMOND VALVED HOLDING CHAMBER
Manufacturer
RESPIRONICS NEW JERSEY, INC.
Date Cleared
2011-08-09
(189 days)
Product Code
NVP
Regulation Number
868.5630Why did this record match?
Product Code :
NVP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The OptiChamber Diamond Valved Holding Chamber device is intended to be used by patients who are under the care or treatment of a physician or licensed healthcare professional. The device is intended to be used by these patients to administer aerosolized medication from most pressurized Metered Dose Inhalers. The intended environments for use include the home, hospitals and clinics.
For Single Patient Use .
Recommended Patient Population:
OptiChamber Diamond: Age 5 and up
OptiChamber Diamond with Small LiteTouch mask: 0 to 18 months
OptiChamber Diamond with Medium LiteTouch mask: 1 to 5 years
OptiChamber Diamond with Large LiteTouch mask: 5 years +
Device Description
The OptiChamber Diamond Valved Holding Chamber (VHC) is a Class II device. It is intended to be used in combination with most pressurized Metered Dose Inhalers (pMDIs) to assist in respiratory drug delivery.
The OptiChamber Diamond Valved Holding Chamber is a device utilizing the same operating principles as the AeroChamber Plus Z-Stat Valved Holding Chamber (K052332). Both the AeroChamber Plus Z-Stat and the OptiChamber Diamond are available with and without mask.
The valved holding chamber (VHC) is designed to assist patients who cannot correctly coordinate actuation of the pressurized metered dose inhaler (pMDIs) with inhalation. The VHC works by 'holding' the aerosol cloud emitted from the pMDI inside the chamber so that the larger aerosol particles are removed from the aerosol cloud by impaction into the chamber walls and sedimentation under the influence of gravity.
The OptiChamber Diamond Valved Holding Chamber is made of antistatic plastic materials alleviating any need to wash prior to first use. OptiChamber Diamond is comprised of: the mouthpiece, the chamber, the adapter (end cap) with inhalation flow alert, the exhaust valve, the inhalation valve, the valve retaining ring, and the cap.
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