Aquastat SFR
Pre-filled Flush Syringe with 0.9% NaCL (saline), 10mL, Sterile Field Ready
10manufacturers in China registered for this device type
2catalogue numbers in this listing
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 | Mrp Group, Inc., United States |
|---|---|
| FDA product code | NGT |
| Device type | Saline, Vascular Access Flush |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5200 |
| 510(k) | K120836 |
| Record published | 2016-09-23 |
| Record revised | 2018-07-06 (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 |
| Packaging | Case of 4 |
| Sizes | Total volume 10 ml |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 2S0706 | Total Volume 10 ml | 60 | In distribution |
| 2S0708 | 20 Milliliter | 80 | 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
Recalls Naming This Product
2 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 |
|---|---|---|---|---|---|---|---|
| Aquabiliti | 510(k) number | 2015-07-02 | Class II | Packaging process control | Procedures for the acceptance and control of in-process product have not been adequately established. | 551 cases | 2017-04-03 |
| Aquabiliti | 510(k) number | 2015-02-09 | Class II | Process control | Incorrect labeling of the expiration date | 1,080 units (3 cases) | 2015-06-22 |
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.