FDA 510(k)

Praxiject 0.9% NaCl

K-Number: K192414 · 2020-02-13

Decision Date2020-02-13

Product CodeNGT

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

Praxiject 0.9% NaCl is a medical device manufactured by Medxl, Inc.. It received FDA 510(k) clearance on 2020-02-13 under approval number K192414. The device is classified under product code NGT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Praxiject 0.9% NaCl?

Praxiject 0.9% NaCl is a medical device that received FDA 510(k) clearance on 2020-02-13. It is manufactured by Medxl, Inc.. The 510(k) number is K192414.

When was Praxiject 0.9% NaCl approved by the FDA?

Praxiject 0.9% NaCl received FDA 510(k) clearance on 2020-02-13, under approval number K192414.

What company makes Praxiject 0.9% NaCl?

Praxiject 0.9% NaCl is manufactured by Medxl, Inc..

What is the FDA product code for Praxiject 0.9% NaCl?

The FDA product code for Praxiject 0.9% NaCl is NGT.

Other Devices by Medxl, Inc.

K171109Praxiject 0.9% NaCl K231754Praxiject 0.9% NaCl K233623Praxiject SP 0.9% NaCl

Related Devices (Code: NGT)

K1534810.9% Sodium Chloride Injection, USP BD PosiFlush SF SyringeBecton, Dickinson and Company K171109Praxiject 0.9% NaClMedxl, Inc. K1615520.9% Sodium Chloride Injection, USP BD PosiFlush SP SyringeBecton, Dickinson and Company K1733480.9% Sodium Chloride Injection, USPMedline Industries, Inc. K1913780.9% Sodium Chloride Injection, USP, Pre-filled COP SyringeMedline Industries, Inc. K183473AMSafe(R) Pre-Filled Normal Saline Flush SyringeAmsino International, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.