BD PosiFlush
Syringe 10ML Short PR Saline 10ML Fill
10manufacturers in China registered for this device type
4catalogue numbers in this listing
5510(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 | Becton, Dickinson AND Company, 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, Repacker / relabeller, Manufacturer |
| 510(k) | K161552 |
| Record published | 2021-11-05 |
| Record revised | 2025-08-07 (version 3) |
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 20 to 25 °C; Special storage condition: Do not freeze |
| Packaging | Case of 16, pack or inner pack of 30, case of 8, shelfpack of 30 |
| Sizes | Total volume 10 ml |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 306495 | Size = Fill Volume = 5 millilitre (mL) | In distribution |
| 306499 | Total Volume 10 ml | In distribution |
| 306493 | Size = Syringe Volume = 10 millilitre (mL) | In distribution |
| 306553 | 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 |
|---|---|
| K250884 | 2025-12-02 |
| K231161 | 2023-07-21 |
| K161552 | 2017-02-02 |
| K153481 | 2016-04-04 |
| K141311 | 2014-07-25 |
Recalls Naming This Product
4 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Becton, Dickinson & Co. | 510(k) number | 2023-11-16 | Class II | Under Investigation by firm | An incorrect stopper was used in nine lots of 10mL BD PosiFlush Normal Saline Flush Syringes with General Pump Compatibility. The use of BD PosiFlush Prefilled Flush Syringes with this stopper causes an increase in injection force, which ha | 5,085,120 units | |
| Becton, Dickinson & Co. | 510(k) number | 2020-04-16 | Class II | Under Investigation by firm | This product has been confirmed to exhibit holes in the packaging, which impacts package integrity and potentially compromises a sterile field. | 16,099,310 units | 2021-09-01 |
| Becton, Dickinson & Co. | 510(k) number | 2019-10-14 | Class II | Packaging process control | Limited number of syringes labeled Posiflush Experimental Product and Not for Human Use being mixed with standard BD Posiflush Pre-Filled Normal Saline Syringes. | 1,632,000 | 2020-10-16 |
| Becton, Dickinson & Co. | 510(k) number | 2019-10-14 | Class II | Packaging process control | Limited number of syringes labeled Posiflush Experimental Product and Not for Human Use being mixed with standard BD Posiflush Pre-Filled Normal Saline Syringes. | 967,680 | 2020-10-16 |
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.