Portex 4143

• FDA 510(k) K946289 decided 10 Jul 1995 Active
• FDA GUDID UDI-DI 20351688051056 listed 5 Jul 2017 Listed

1. 10 Jul 1995 Cleared FDA 510(k) K946289
2. 5 Jul 2017 Listed FDA GUDID 20351688051056

Trade name

Portex

Generic name

Needle guard

Model / reference

4143

Primary DI / UDI-DI

20351688051056

510(k) Number

K946289 ↗

FDA product code

FMI

GMDN term

Needle guard

Device class

Class II

Regulation number

880.5570

GUDID distribution status

In Commercial Distribution

Category: Needle guard

Other devices filed under FDA product code FMI (Needle, hypodermic, single lumen).

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• NIO+ Adult by WaisMed Ltd
• PD-IO DISPOSABLE INTRAOSSEOUS INFUSION NEEDLE by Vidacare Corporation
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• F.A.S.T. 1 INTRAOSSEOUS INFUSION SYSTEM by Pyng Medical Corp.
• Micsafe 1 by Jiangsu Micsafe Medical Tehcnology Co., LTD.
• SIMPLICITY DISPOSABLE PEN NEEDLE by Sterling Medivations, Inc.

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See all devices from ICU Medical, Inc. →