21 CFR 880.5430 — Injector, Fluid, Non-Electrically Powered

General Hospital (HO) · Part 880 Subpart F—General Hospital and Personal Use Therapeutic Devices · § 880.5430

Identification

A nonelectrically powered fluid injector is a nonelectrically powered device used by a health care provider to give a hypodermic injection by means of a narrow, high velocity jet of fluid which can penetrate the surface of the skin and deliver the fluid to the body. It may be used for mass inoculations.

Classification Rationale

Class II (performance standards).

Product Codes

Product CodeDevice NameClassDevicesAttributes
KZEInjector, Fluid, Non-Electrically Powered253
Innolitics

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