FDA 510(k) Applications for Medical Device Product Code "NGT"
(Saline, Vascular Access Flush)

FDA 510(k) Number Applicant Device Name Decision Date
K111034 AM USA AM USA 0.9% SODIUM CHLORIDE FLUSH SYRINGE 07/14/2011
K113555 AM USA AM USA 0.9% SODIUM CHLORIDE FLUSH SYRINGE 01/30/2012
K213522 Amsino International, Inc. AMSafe Pre-Filled Normal Saline Flush Syringe 03/22/2022
K183473 Amsino International, Inc. AMSafe(R) Pre-Filled Normal Saline Flush Syringe 07/12/2019
K120836 AMUSA 0.9% SODIUM CHLORIDE FLISH SYRINGE 07/12/2012
K133685 AMUSA 0.9% SODIUM CHLORIDE FLUSH SYRINGE 08/13/2014
K230756 Anhui Tiankang Medical Technology Co., Ltd. TK Pre-Filled Normal Saline Flush Syringe 08/12/2023
K223584 Anhui Tianyang Pharmaceutical Co., Ltd. Pre-Filled Normal Saline Flush Syringe 08/12/2023
K042061 BECTON DICKINSON 0.9% SODIUM CHLORIDE INJECTION, USP BD POSTFLUSH SF FLUSH SYRINGE 08/26/2004
K121050 BECTON DICKINSON & CO. 0.9% SODIUM CHLORIDE INJECTION USP BD POSIFLUSH FLUSH SYRINGE, SF FLUSH SYRINGE 02/07/2013
K161552 Becton Dickinson and Company 0.9% Sodium Chloride Injection, USP BD PosiFlush SP Syringe 02/02/2017
K153481 BECTON, DICKINSON AND COMPANY 0.9% Sodium Chloride Injection, USP BD PosiFlush SF Syringe 04/04/2016
K141311 Becton, Dickinson and Company 0.9% SODIUM CHLORIDE INJECTION, USP BD POSIFLUSH; SP SYRINGE, SF SYRINGE 07/25/2014
K231161 Becton, Dickinson and Company 0.9% Sodium Chloride Injection, USP BD PosiFlushÖ SF Saline Flush Syringe 07/21/2023
K082837 EXCELSIOR MEDICAL CORP. STERILE FIELD SALINE PRE-FILLED SYRINGE(S) 12/18/2008
K101270 EXCELSIOR MEDICAL CORP. SWABFLSUH (3ML, 5ML, 10ML) MODEL 10331, 10351, 10311 02/10/2011
K142620 Excelsior Medical Corporation 0.9% Sodium Chloride Injection, USP - 2.5 mL in 3 mL Syringe, 0.9% Sodium Chloride Injection, USP-3mL in 10 mL Syringe, 0.9% Sodium Chloride Injection, USP - 5 mL in 10 mL Syringe, 0.9% Sodium Chloride Injection, USP - 10 mL in 10 mL Syringe 12/12/2014
K231363 Hantech Medical Device Co., Ltd. Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, PFS-1010) 09/27/2023
K090882 HOSPIRA, INC. FLUSH SYRINGE FILLED WITH 0.9% SODIUM CHLORIDE 04/23/2010
K121231 IND NDIAGNOSTIC INC. IND DRUG HOME MULTI-PANEL TEST (2-5) IND MORPHINE HOME TEST 07/30/2012
K220060 Jiangsu Caina Medical Co., Ltd. Pre-filled Syringe with Saline 06/10/2022
K020996 MEDEFIL, INC. MEDEFIL'S HEPARIN I.V. FLUSH SYRINGE IN VARIOUS FILL SIZES - 1 ML FILL IN 6 ML SYRINGE LL; 2 ML FILL IN 6 ML SYRINGE LL 06/24/2002
K020999 MEDEFIL, INC. MEDEFIL'S NORMAL SALINE FLUSH SYRINGE IN VARIOUS FILL SIZES - 1 ML FILL IN 6 ML SYRINGE LL; 2 ML FILL IN 6 ML SYRINGE LL 06/20/2002
K091583 MEDEFIL, INC. MEDEFIL'S NORMAL SALINE I.V. FLUSH SYRINGE 01/28/2010
K121262 MEDEFIL, INC. MEDEFLUSH NORMAL SALINE I.V. FLUSH SYRINGE-STERILE FIELD READY 09/20/2012
K173348 Medline Industries, Inc. 0.9% Sodium Chloride Injection, USP 06/21/2018
K191378 Medline Industries, Inc. 0.9% Sodium Chloride Injection, USP, Pre-filled COP Syringe 09/15/2019
K171109 MedXL Inc. Praxiject 0.9% NaCl 12/21/2017
K192414 MedXL Inc. Praxiject 0.9% NaCl 02/13/2020
K231754 MedXL Inc. PraxijectÖ 0.9% NaCl 07/13/2023
K150143 NURSE ASSIST, INC. Normal Saline Flush 08/31/2015
K201286 Nurse Assist, LLC 0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 1 syringe/pouch, 0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 2 syringes/pouch 08/11/2020
K214080 PENTAFERTE ITALIA S.R.L. Pentaflush 07/20/2022
K103740 SPECTRA MEDICAL DEVICES, INC. SODIUM CHLORIDE INJECTION, 0.9%, USP 5 ML, 10 ML AMPULE 07/29/2011
K082689 SPECTRA MEDICAL DEVICES, INC. STERILE SODIUM CHLORIDE 0.9% FLUSH, 5ML, 10ML, AMPULE 03/20/2009
K011283 THE KENDALL COMPANY MONOJECT PREFILL 0.9% SODIUM CHLORIDE FLUSH SYRINGE 10/15/2001
K032438 TYCO HEALTHCARE MODIFICATION TO: MONOJET PREFILL 0.9% SODIUM CHLORIDE FLUSH SYRINGE, MONOJET PREFILL HEPRIN LOCK FLUSH SYRINGE 06/30/2004
K060339 TYCO HEALTHCARE/KENDALL KENDALL MONOJECT PRE-FILL ADVANCED 0.9%SODIUM CHLORIDE FLUSH SYRINGES FOR STERILE DELIVERY 04/28/2006


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