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FDA 510(k)

Praxiject 0.9% NaCl

K-Number: K192414 · 2020-02-13

ApplicantMedxl, Inc.
Decision Date2020-02-13
Product CodeNGT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Praxiject 0.9% NaCl is the device name listed in this FDA 510(k) record. The listed applicant is Medxl, Inc.. It received FDA 510(k) clearance on 2020-02-13 under 510(k) 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. The listed applicant is Medxl, Inc.. The 510(k) number is K192414.

When did Praxiject 0.9% NaCl receive FDA 510(k) clearance?

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

Who is the listed applicant for Praxiject 0.9% NaCl?

The FDA 510(k) record lists Medxl, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Medxl, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K233623Praxiject™ SP 0.9% NaClK231754Praxiject™ 0.9% NaClK171109Praxiject 0.9% NaCl

Related Devices (Code: NGT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K2508840.9 % Sodium Chloride Injection, USP, BD PosiFlush™ SP SyringeBecton, Dickinson and CompanyK233623Praxiject™ SP 0.9% NaClMedxl, Inc.K231724Flush Syringe (Prefilled 0.9% normal saline solution)Spm Medicare Pvt. , Ltd.K231363Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, PFS-1010)Hantech Medical Device Co., Ltd.K230756TK Pre-Filled Normal Saline Flush SyringeAnhui Tiankang Medical Technology Co., Ltd.K223584Pre-Filled Normal Saline Flush SyringeAnhui Tianyang Pharmaceutical Co., Ltd.

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.

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