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.9% Normal Saline Tube/Sterile Water Tube

by Gam-Med Packaging Corp.

510(k) K926405

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK926405 Date3 Feb 1994ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
FOZ
Device Class
Class II
Regulation
21 CFR Part 880.5200
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

This device is a .9% Normal Saline Tube/Sterile Water Tube, which is a sterile solution of sodium chloride in water for injection. It contains no antimicrobial agents and is formulated to contain not less than 95.0% and not more than 105.0% of the labeled amount of sodium chloride (NaCl).

The device is supplied in a sterile, ready-to-use container and is intended for use in general hospital settings. It received FDA 510(k) clearance under K926405 on February 3, 1994, and is classified under product code FOZ. The device is sterile and intended for single use.

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Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the .9% Normal Saline Tube/Sterile Water Tube used for?

    It is a sterile solution of sodium chloride in water for injection, intended for use in general hospital settings where a sterile isotonic saline solution is required, such as for wound irrigation, medication dilution, or fluid replacement, as it contains no antimicrobial agents and is formulated to deliver precise sodium chloride concentration.

  • How is the .9% Normal Saline Tube supplied and is it sterile?

    The device is supplied in a sterile, ready-to-use container, ensuring it is free from microorganisms at the point of use, and is designed for immediate application in clinical environments without additional preparation.

  • Is the .9% Normal Saline Tube single-use or reusable?

    The device is intended for single use only, as stated in the device description, to prevent contamination and ensure patient safety, and should be discarded after one procedure.

  • What regulatory clearance does the .9% Normal Saline Tube have?

    It received FDA 510(k) clearance under K926405 on February 3, 1994, and is classified under product code FOZ, indicating it was found substantially equivalent to a legally marketed predicate device.