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510(k) Data Aggregation
K Number
K233553Device Name
MiniSpacer® 1024, 1025, 1543 and 1024A, 1025A, 1543A Dual Spray MDI Adapter
Manufacturer
Thayer Medical Corporation
Date Cleared
2024-06-18
(225 days)
Product Code
CAF
Regulation Number
868.5630Why did this record match?
Applicant Name (Manufacturer) :
Thayer Medical Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Model number 1024 is a single patient, disposable device for dispensing pressurized metered dose inhaler (pMDI) medication into a breathing circuit, as prescribed by a physician or other licensed health care practitioner. The device is indicated for patients on a breathing circuit, for whom aerosol medication has been prescribed, in short and long term critical care environments. REF 1024 is intended for use only when connected to a 22 mm fitting.
Model number 1024A is a single patient, disposable device for dispensing pressurized metered dose inhaler (pMDI) medication into a breathing circuit, as prescribed by a physician or other licensed health care practitioner. The device is indicated for patients on a breathing circuit, for whom aerosol medication has been prescribed, in short and long term critical care environments. REF 1024A is intended for use only when connected to a 22 mm fitting.
Model number 1025 is a single patient, disposable device for dispensing pressurized metered dose inhaler (pMDI) medication into a breathing circuit, as prescribed by a physician or other licensed health care practitioner. The device is indicated for patients on a breathing circuit, for whom aerosol medication has been prescribed, in short and long term critical care environments. REF 1025 is intended for use only when connected to a 22 mm fitting.
Model number 1025A is a single patient, disposable device for dispensing pressurized metered dose inhaler (pMDI) medication into a breathing circuit, as prescribed by a physician or other licensed health care practitioner. The device is indicated for patients on a breathing circuit, for whom aerosol medication has been prescribed, in short and long term critical care environments. REF 1025A is intended for use only when connected to a 22 mm fitting.
Model number 1543 is a single patient, disposable device for dispensing pressurized metered dose inhaler (pMDI) medication into a breathing circuit, as prescribed by a physician or other licensed health care practitioner. The device is indicated for patients on a breathing circuit, for whom aerosol medication has been prescribed, in short and long term critical care environments. REF 1543 is intended for use only when connected to a 15 mm fitting.
Model number 1543A is a single patient, disposable device for dispensing pressurized metered dose inhaler (pMDI) medication into a breathing circuit, as prescribed by a physician or other licensed health care practitioner. The device is indicated for patients on a breathing circuit, for whom aerosol medication has been prescribed, in short and long term critical care environments. REF 1543A is intended for use only when connected to a 15 mm fitting.
Device Description
Model numbers 1024, 1025, 1543, 1024A, 1025A and 1543A are breathing circuit connectors that function as general purpose actuators for dispensing prescribed aerosolized medication from a pressurized metered dose inhaler (hereafter referred to as "pMDI") canister into a breathing circuit.
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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?
Applicant Name (Manufacturer) :
Thayer Medical Corporation
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
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?
Applicant Name (Manufacturer) :
THAYER MEDICAL CORPORATION
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
K111570Device Name
MINISPACER(R) MDI ADAPTER WITH COUNTER INCREMENTING ACTUATOR
Manufacturer
THAYER MEDICAL CORPORATION
Date Cleared
2011-09-29
(115 days)
Product Code
CAF
Regulation Number
868.5630Why did this record match?
Applicant Name (Manufacturer) :
THAYER MEDICAL CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MINISPACER® 1024A, 1025A and 1543A adapters are single patient, disposable devices for dispensing pressurized metered dose inhaler (pMDI) medication into a breathing circuit, as prescribed by a physician or other licensed health care practitioner.
The MINISPACER® 1024A, 1025A and 1543A adapters are indicated for patients on a breathing circuit, for whom aerosol medication has been prescribed, in short and long term critical care environments.
Device Description
Not Found
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