Excelsior
0.9% Sodium Chloride Injection, USP
10manufacturers in China registered for this device type
28catalogue numbers in this listing
2510(k) clearances naming this product code
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 | Medline Industries, Inc., United States |
|---|---|
| FDA product code | NGT |
| Device type | Saline, Vascular Access Flush |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5200 |
| 510(k) | K130975 |
| Record published | 2016-09-19 |
| Record revised | 2022-09-16 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| 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; Special storage condition: Protect from freezing |
| Packaging | Case of 8, case of 6, case of 10, case of 16, case of 12 |
| Sizes | Total volume 2.5 to 10 ml |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 10051 | Total Volume 5 ml | 100 | In distribution |
| 17012 | 10mL fill in 10mL flush syringe | 100 | In distribution |
| 10011 | 10mL fill in 10mL flush syringe | 100 | In distribution |
| 10035 | Total Volume 3 ml | 100 | In distribution |
| 731-800 | 3 mL fill in 10 mL flush syringe with integrated SwabCap® | 100 | In distribution |
| 10091-280 | Total Volume 10 ml | 100 | In distribution |
| E0103-55 | Total Volume 5 ml | 100 | In distribution |
| E0100-30 | Total Volume 2.5 ml | 100 | In distribution |
| 10011 | Total Volume 10 ml | 100 | In distribution |
| E0103-01 | 10 mL fill in 10 mL flush syringe with integrated SwabCap® | 100 | In distribution |
| E0104-30 | Kit including 2.5 mL fill in 3 mL flush syringe and SwabCap® | 100 | In distribution |
| 10051 | Total Volume 5 ml | 100 | In distribution |
| 10033 | 2.5 mL fill in 3 mL flush syringe | 100 | In distribution |
| E0103-35 | 3 mL fill in 10 mL flush syringe with integrated SwabCap® | 100 | In distribution |
| 10011 | 10mL fill in 10mL flush syringe | 100 | In distribution |
| 751-600 | 5 mL fill in 10 mL flush syringe with integrated SwabCap® | 100 | In distribution |
| 10011 | 10mL fill in 10mL flush syringe | 100 | In distribution |
| 10051 | Total Volume 5 ml | 100 | In distribution |
| 10051 | Total Volume 5 ml | 100 | In distribution |
| 10011 | Total Volume 10 ml | 100 | In distribution |
| 10033 | Total Volume 2.5 ml | 100 | In distribution |
| 10051 | Total Volume 5 ml | 100 | In distribution |
| 17011 | 10mL fill in 10mL flush syringe | 100 | In distribution |
| E0100-01 | 10 mL fill in 10 mL flush syringe | 100 | In distribution |
| E0100-55 | Total Volume 5 ml | 100 | In distribution |
| 10035 | 3 mL fill in 10 mL flush syringe | 100 | In distribution |
| 10035 | Total Volume 3 ml | 100 | In distribution |
| 711-600 | 10 mL fill in 10 mL flush syringe with integrated SwabCap® | 100 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| Halyard | O&M Halyard, Inc. | 4 |
Showing 12 of 35. All products under Saline, Vascular Access Flush
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K191378 | 2019-09-15 |
| K173348 | 2018-06-21 |
Recalls Naming This Product
3 recalls name this product by its own identifiers, the UDI on its label or the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Medline Industries, LP – Northfield | UDI-DI | 2025-09-11 | Class II | Process control | Medline has identified a limited quantity of saline IV flush syringes that may not meet the required concentration of sodium chloride. | 8,267,150 syringes | |
| Medline Industries, LP – Northfield | UDI-DI | 2025-06-16 | Class II | Process control | SwabFlush syringes are affected by the ICU Medical recall of their SwabCap Disinfecting Cap due to a manufacturing issue which affects the seal between the foil lid and plastic container of the Swab Cap. The issue may result in a reduced le | 1,427,100 eaches | |
| Medline Industries, LP – Northfield | 510(k) number | 2022-03-04 | Class II | Material/Component Contamination | Sterility failure of the exterior of the syringe which may impact the device’s ability to be laid on a sterile field. | 7,800 pouched syringes | 2023-03-20 |
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.