Product code

NVP: Holding chambers, direct patient interface

FDA product code · Class II · Anesthesiology

Key facts

Product code NVP
Device Holding chambers, direct patient interface
Device class Class II
Regulation number 868.5630
Review panel Anesthesiology
Medical specialty Anesthesiology
Submission type 510(k)
GMP exempt No
Implanted device No
Life-sustaining or life-supporting No
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

At a glance

  • 10–99 510(k) clearances
  • None De Novo grants
  • None PMA approvals
  • None HDE approvals
  • 10–99 UDI devices (GUDID)
  • 10–99 MAUDE adverse event reports
  • 1–9 Recalled products (Z-numbers)

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device product codes

FDA product codes classify medical devices by type and intended use; each code maps to a device class, a classification regulation and a review panel.

Source: U.S. Food and Drug Administration (FDA), Product Classification database

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