FDA Product Code
FDA Product Code NGT — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General Hospital
- 21 CFR Citation
- 880.5200
510(k) Clearances — 40 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K250884 | 0.9 % Sodium Chloride Injection, USP, BD PosiFlush SP Syringe | Becton, Dickinson and Company | 2025-12-02 | Traditional | PDF ↗ |
| K233623 | Praxiject SP 0.9% NaCl | Medxl, Inc. | 2024-02-27 | Traditional | PDF ↗ |
| K231724 | Flush Syringe (Prefilled 0.9% normal saline solution) | Spm Medicare Pvt. , Ltd. | 2023-11-09 | Traditional | PDF ↗ |
| K231363 | Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, PFS-1010) | Hantech Medical Device Co., Ltd. | 2023-09-27 | Traditional | PDF ↗ |
| K223584 | Pre-Filled Normal Saline Flush Syringe | Anhui Tianyang Pharmaceutical Co., Ltd. | 2023-08-12 | Traditional | PDF ↗ |
| K230756 | TK Pre-Filled Normal Saline Flush Syringe | Anhui Tiankang Medical Technology Co., Ltd. | 2023-08-12 | Traditional | PDF ↗ |
| K231161 | 0.9% Sodium Chloride Injection, USP BD PosiFlush SF Saline Flush Syringe | Becton, Dickinson and Company | 2023-07-21 | Traditional | PDF ↗ |
| K231754 | Praxiject 0.9% NaCl | Medxl, Inc. | 2023-07-13 | Special | PDF ↗ |
| K214080 | Pentaflush | Pentaferte Italia S.R.L. | 2022-07-20 | Traditional | PDF ↗ |
| K213522 | AMSafe Pre-Filled Normal Saline Flush Syringe | Amsino International, Inc. | 2022-03-22 | Traditional | PDF ↗ |
| K201286 | 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 | Nurse Assist, LLC | 2020-08-11 | Traditional | PDF ↗ |
| K192414 | Praxiject 0.9% NaCl | Medxl, Inc. | 2020-02-13 | Special | PDF ↗ |
| K191378 | 0.9% Sodium Chloride Injection, USP, Pre-filled COP Syringe | Medline Industries, Inc. | 2019-09-15 | Traditional | PDF ↗ |
| K183473 | AMSafe(R) Pre-Filled Normal Saline Flush Syringe | Amsino International, Inc. | 2019-07-12 | Traditional | PDF ↗ |
| K173348 | 0.9% Sodium Chloride Injection, USP | Medline Industries, Inc. | 2018-06-21 | Traditional | PDF ↗ |
| K171109 | Praxiject 0.9% NaCl | Medxl, Inc. | 2017-12-21 | Traditional | PDF ↗ |
| K161552 | 0.9% Sodium Chloride Injection, USP BD PosiFlush SP Syringe | Becton, Dickinson and Company | 2017-02-02 | Special | PDF ↗ |
| K153481 | 0.9% Sodium Chloride Injection, USP BD PosiFlush SF Syringe | Becton, Dickinson and Company | 2016-04-04 | Traditional | PDF ↗ |
| K150143 | Normal Saline Flush | Nurse Assist, Inc. | 2015-08-31 | Traditional | PDF ↗ |
| K142620 | 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 | Excelsior Medical Corporation | 2014-12-12 | Traditional | PDF ↗ |
| K133685 | 0.9% SODIUM CHLORIDE FLUSH SYRINGE | Am USA | 2014-08-13 | Traditional | PDF ↗ |
| K141311 | 0.9% SODIUM CHLORIDE INJECTION, USP BD POSIFLUSH; SP SYRINGE, SF SYRINGE | Becton, Dickinson and Company | 2014-07-25 | Special | PDF ↗ |
| K121050 | 0.9% SODIUM CHLORIDE INJECTION USP BD POSIFLUSH FLUSH SYRINGE, SF FLUSH SYRINGE | Becton, Dickinson & CO | 2013-02-07 | Traditional | PDF ↗ |
| K121262 | MEDEFLUSH NORMAL SALINE I.V. FLUSH SYRINGE-STERILE FIELD READY | Medefil, Inc. | 2012-09-20 | Special | PDF ↗ |
| K121231 | IND DRUG HOME MULTI-PANEL TEST (2-5) IND MORPHINE HOME TEST | Ind Ndiagnostic, Inc. | 2012-07-30 | Traditional | PDF ↗ |
| K120836 | 0.9% SODIUM CHLORIDE FLISH SYRINGE | Am USA | 2012-07-12 | Special | PDF ↗ |
| K113555 | AM USA 0.9% SODIUM CHLORIDE FLUSH SYRINGE | Am USA | 2012-01-30 | Special | PDF ↗ |
| K103740 | SODIUM CHLORIDE INJECTION, 0.9%, USP 5 ML, 10 ML AMPULE | Spectra Medical Devices, Inc. | 2011-07-29 | Traditional | PDF ↗ |
| K111034 | AM USA 0.9% SODIUM CHLORIDE FLUSH SYRINGE | Am USA | 2011-07-14 | Special | PDF ↗ |
| K101270 | SWABFLSUH (3ML, 5ML, 10ML) MODEL 10331, 10351, 10311 | Excelsior Medical Corp. | 2011-02-10 | Traditional | PDF ↗ |
| K090882 | FLUSH SYRINGE FILLED WITH 0.9% SODIUM CHLORIDE | Hospira, Inc. | 2010-04-23 | Traditional | PDF ↗ |
| K091583 | MEDEFIL'S NORMAL SALINE I.V. FLUSH SYRINGE | Medefil, Inc. | 2010-01-28 | Special | PDF ↗ |
| K082689 | STERILE SODIUM CHLORIDE 0.9% FLUSH, 5ML, 10ML, AMPULE | Spectra Medical Devices, Inc. | 2009-03-20 | Traditional | PDF ↗ |
| K082837 | STERILE FIELD SALINE PRE-FILLED SYRINGE(S) | Excelsior Medical Corp. | 2008-12-18 | Special | PDF ↗ |
| K060339 | KENDALL MONOJECT PRE-FILL ADVANCED 0.9%SODIUM CHLORIDE FLUSH SYRINGES FOR STERILE DELIVERY | Tyco Healthcare/Kendall | 2006-04-28 | Special | PDF ↗ |
| K042061 | 0.9% SODIUM CHLORIDE INJECTION, USP BD POSTFLUSH SF FLUSH SYRINGE | Becton Dickinson | 2004-08-26 | Special | PDF ↗ |
| K032438 | MODIFICATION TO: MONOJET PREFILL 0.9% SODIUM CHLORIDE FLUSH SYRINGE, MONOJET PREFILL HEPRIN LOCK FLUSH SYRINGE | Tyco Healthcare | 2004-06-30 | Traditional | PDF ↗ |
| K020996 | 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 | Medefil, Inc. | 2002-06-24 | Traditional | PDF ↗ |
| K020999 | 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 | Medefil, Inc. | 2002-06-20 | Traditional | PDF ↗ |
| K011283 | MONOJECT PREFILL 0.9% SODIUM CHLORIDE FLUSH SYRINGE | The Kendall Company | 2001-10-15 | Traditional | PDF ↗ |
Product code NGT · Class II · General Hospital. Data: openFDA.