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510(k) Data Aggregation
K Number
K140919Device Name
RESPICONNECT ADAPTER
Manufacturer
TRUDELL MEDICAL INT'L
Date Cleared
2014-08-15
(127 days)
Product Code
CAF
Regulation Number
868.5630Why did this record match?
Applicant Name (Manufacturer) :
TRUDELL MEDICAL INT'L
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The RespiConnect Adapter is designed to be used with RESPIMAT™ SOFT MIST INHALERS to facilitate the delivery of bronchodilator aerosol medication to mechanically ventilated patients. The single patient use adapter is intended to be left in the inspiratory limb of a 22 mm ventilator circuit.
Device Description
The RespiConnect Adapter is a single-patient use device intended to provide a self-sealing access port in a ventilator circuit to facilitate the administration of Respimat™ Soft Mist inhaler medication to mechanically ventilated patients.
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K Number
K001137Device Name
AEROTRACH PLUS VALVED HOLDING CHAMBER (VHC)
Manufacturer
TRUDELL MEDICAL INT'L
Date Cleared
2000-07-05
(86 days)
Product Code
CAF
Regulation Number
868.5630Why did this record match?
Applicant Name (Manufacturer) :
TRUDELL MEDICAL INT'L
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K992917Device Name
AEROCHAMBER PLUS VALVED HOLDING CHAMBER
Manufacturer
TRUDELL MEDICAL INT'L
Date Cleared
1999-09-14
(15 days)
Product Code
CAF
Regulation Number
868.5630Why did this record match?
Applicant Name (Manufacturer) :
TRUDELL MEDICAL INT'L
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The "AeroChamber® Plus Valved Holding Chamber is intended to be used by patients who are under the care or treatment of a licensed health care professional or physician. The device is intended to by 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 the home, hospitals and clinics.
Device Description
Not Found
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