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Spacer, Direct Patient Interface

Page Type
Product Code
Definition
Spacers are devices that are used with nebulizers and metered dose inhalers that are comprised of a reservior into which an aerosol medication is dispensed. A spacer uses an open mouthpiece. Spacers are intended to minimize delivery of large aerosolized particles.
Physical State
Spacers are frequently made of plastic, and can be tube shapped.
Technical Method
By holding drugs after aerosolization, spacers are intended to minimize delivery of large aerosolized particles, which would otherwise deposit in the mouth.
Target Area
Spacers 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).

Spacer, Direct Patient Interface

Page Type
Product Code
Definition
Spacers are devices that are used with nebulizers and metered dose inhalers that are comprised of a reservior into which an aerosol medication is dispensed. A spacer uses an open mouthpiece. Spacers are intended to minimize delivery of large aerosolized particles.
Physical State
Spacers are frequently made of plastic, and can be tube shapped.
Technical Method
By holding drugs after aerosolization, spacers are intended to minimize delivery of large aerosolized particles, which would otherwise deposit in the mouth.
Target Area
Spacers 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).