Browse hierarchy: [General Hospital (HO)](/submissions/HO) → [Subpart F — General Hospital and Personal Use Therapeutic Devices](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices) → [21 CFR 880.5570](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/880.5570) → QMT — Prep Kit – Vaccine Injection

# QMT · Prep Kit – Vaccine Injection

_General Hospital · 21 CFR 880.5570 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/QMT

## Overview

- **Product Code:** QMT
- **Device Name:** Prep Kit – Vaccine Injection
- **Regulation:** [21 CFR 880.5570](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/880.5570)
- **Device Class:** 2
- **Review Panel:** [General Hospital](/submissions/HO)

## Identification

A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (0 of 0)

_No cleared devices on record._

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**Source:** [https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/QMT](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/QMT)

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