MANAN PEDIATRIC BONE MARROW ACCESS NEEDLE

• K Number: K962001
• Device Name: MANAN PEDIATRIC BONE MARROW ACCESS NEEDLE
• Manufacturer: MANAN MEDICAL PRODUCTS, INC.
• Date Cleared: 1997-01-10 ( 233 days)
• Product Code: FMI
• Regulation Number: 880.5570

Intended Use

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Device Description

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Predicate Devices

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Reference Devices

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AI/ML (Artificial Intelligence / Machine Learning)

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Therapeutic

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Diagnostic

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SaMD (Software as a Medical Device)

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IVD (In Vitro Diagnostic)

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PCCP (Predetermined Change Control Plan) Authorized

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Overview

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Regulation Number and Section

§ 880.5570 Hypodermic single lumen needle.

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

Summary

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