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Holding Chambers, Direct Patient Interface

Page Type
Product Code
Definition
Holding chambers are devices that are used with nebulizers and metered dose inhalers and are comprised of a reservoir into which an aerosol medication is dispensed. A holding chamber uses a valved mouthpiece through which the patient inhales the dispensed medication. Holding chambers are intended to minimize delivery of large aerosolized particles
Physical State
Holding Chambers are frequently made of plastic, and can be tube shaped.
Technical Method
By holding drugs after aerosolization, holding chambers are intended to minimize delivery of large aerosolized particles which would otherwise depisit in the mouth, throat, or upper airway
Target Area
Holding Chambers contact the mouth. The drug they are holding is intended for the lower airways
Regulation Medical Specialty
Anesthesiology
Review Panel
Anesthesiology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
868.5630
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 868.5630 Nebulizer

§ 868.5630 Nebulizer.

(a) Identification. A nebulizer is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. Heated, ultrasonic, gas, venturi, and refillable nebulizers are included in this generic type of device.

(b) Classification. Class II (performance standards).

Holding Chambers, Direct Patient Interface

Page Type
Product Code
Definition
Holding chambers are devices that are used with nebulizers and metered dose inhalers and are comprised of a reservoir into which an aerosol medication is dispensed. A holding chamber uses a valved mouthpiece through which the patient inhales the dispensed medication. Holding chambers are intended to minimize delivery of large aerosolized particles
Physical State
Holding Chambers are frequently made of plastic, and can be tube shaped.
Technical Method
By holding drugs after aerosolization, holding chambers are intended to minimize delivery of large aerosolized particles which would otherwise depisit in the mouth, throat, or upper airway
Target Area
Holding Chambers contact the mouth. The drug they are holding is intended for the lower airways
Regulation Medical Specialty
Anesthesiology
Review Panel
Anesthesiology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
868.5630
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 868.5630 Nebulizer

§ 868.5630 Nebulizer.

(a) Identification. A nebulizer is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. Heated, ultrasonic, gas, venturi, and refillable nebulizers are included in this generic type of device.

(b) Classification. Class II (performance standards).