AMSafe® Pre-Filled Normal Saline Flush Syringe
AMSafe Pre-Filled Normal Saline Flush Syringe is a disposable syringe containing 0.9% sodium chloride injection. It is intended to flush compatible intravenous administration sets and…
AMSafe Pre-Filled Normal Saline Flush Syringe is a disposable syringe containing 0.9% sodium chloride injection. It is intended to flush compatible intravenous administration sets and indwelling intravenous access devices. The syringe has a Luer lock connection and a capped tip.
The syringe and cap are polypropylene. The range includes 3, 5 and 10 mL fills in a 12 mL syringe and a 20 mL fill in a 20 mL syringe. The filled device is terminally sterilized with gamma radiation.
Listed Item
AMSafe ® Pre-Filled Normal Saline Flush Syringe, STERILE FIELD READY, 10mL, use only in flushing compatible intravenous administration sets and indwelling intravenous access device.
Packaging Options
The sterile field version is supplied in a blister package, with the packaged device sterilized for delivery into a sterile field. A separate polypropylene wrapper serves as a dust cover for use outside a sterile field. The syringes are intended for single use and must be matched to compatible intravenous devices.
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 | Amsino Medical Inc., United States |
|---|---|
| FDA product code | NGT |
| Device type | Saline, Vascular Access Flush |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5200 |
| Establishment | Repacker / relabeller |
| 510(k) | K183473 |
| Record published | 2025-06-23 |
| Record revised | 2022-09-09 (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 |
| Packaging | Case of 180, box of 30, case of 6, pouch, case of 240, box of 20 |
| Distribution end date | 2023-08-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Withdrawn | |
| 1 | Withdrawn | |
| 1 | Withdrawn | |
| 1 | Withdrawn | |
| 1 | Withdrawn | |
| 1 | Withdrawn | |
| 1 | Withdrawn | |
| 1 | Withdrawn | |
| 1 | Withdrawn | |
| 1 | Withdrawn | |
| 1 | Withdrawn | |
| 1 | Withdrawn | |
| 1 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Excelsior | Medline Industries, Inc. | 28 |
| 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 |
|---|---|
| K213522 | 2022-03-22 |
| K183473 | 2019-07-12 |
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.