Praxiject™ SP 0.9% NaCl
Praxiject SP is a prefilled syringe for flushing vascular access devices. It contains 10 mL of preservative-free 0.9 percent sodium chloride injection in a plastic piston syringe with a…
Praxiject SP is a prefilled syringe for flushing vascular access devices. It contains 10 mL of preservative-free 0.9 percent sodium chloride injection in a plastic piston syringe with a luer-lock connection.
The tip is closed by a plastic cap, and the device is terminally sterilized with gamma irradiation. Its packaging protects the syringe while maintaining the sterile internal fluid pathway.
Listed Item
10 mL of 0.9% Sodium Chloride Injection USP in a 10 mL syringe, gamma irradiation
Sterile Fluid Path
The individual flow-wrapped pouch is a protective dust barrier rather than a sterile-field package. The SP syringe is intended for single use and must not be placed on a sterile field. Its purpose is vascular-access flushing rather than general injection of medications.
Who Else Makes It
Concentrated in Zhejiang (4), Jiangsu (2), Anhui (2). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hantech (Ningbo) Medical Technology Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 3 |
| Jiaxing Tianhe Pharmaceutical Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 1 |
| Huzhou Junda Industry Co., Ltd. | Anji | Zhejiang | Contract manufacturer | 129 |
| Amsino Medical (Kunshan) Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 53 |
| Jinan Babio Biotechnology Co., Ltd. | Jinan | Shandong | Manufacturer | 25 |
| Hantech Medical Device Co., Ltd. | Cixi | Zhejiang | Contract manufacturer | 18 |
| Suzhou Cnnc Huadong Radiation Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 12 |
| Anhui Tiankang Medical Technology Co., Ltd. | Tianchang | Anhui | Contract manufacturer | 9 |
| Lucky Star Lrradiation Science Co., Ltd. Shanghai | Shanghai | Shanghai | Contract manufacturer | 5 |
| Anhui Tianyang Pharmaceutical Co., Ltd. | Tianchang | Anhui | Manufacturer | 1 |
Record
| Listed by | MedXL, United States |
|---|---|
| FDA product code | NGT |
| Device type | Saline, Vascular Access Flush |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5200 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Private-label distributor, Manufacturer |
| 510(k) | K233623 |
| Record published | 2024-07-25 |
| Record revised | 2026-07-30 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 15 to 30 °C |
| Packaging | Box of 30, case of 6 |
| Sizes | Total volume 10 ml |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 3705-3 | 10 mL fill in 10 mL syringe | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Excelsior | Medline Industries, Inc. | 28 |
| AMSafe® Pre-Filled Normal Saline Flush Syringe | Amsino Medical Inc. | 25 |
| Monoject | Cardinal Health | 19 |
| Nurse Assist | Nurse Assist, LLC | 13 |
| Ceros | Rhino Medical Supply Inc | 8 |
| Praxiject™ 0.9% NaCl | MedXL | 7 |
| McKesson | Mckesson Medical-Surgical Inc. | 7 |
| Normal Saline IV Flush Syringe | Medefil, Inc. | 6 |
| Easy Flush | SPM Medicare PVT, Ltd. | 6 |
| Covidien | Nurse Assist, LLC | 6 |
| Gbuk | Jiangsu Caina Medical Co., Ltd. | 5 |
| Cardinal Health | Cardinal Health 200, LLC | 4 |
Showing 12 of 35. All products under Saline, Vascular Access Flush
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K233623 | 2024-02-27 |
| K231754 | 2023-07-13 |
| K192414 | 2020-02-13 |
| K171109 | 2017-12-21 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.