Normal Saline IV Flush Syringe
Medefil Normal Saline IV Flush Syringe, 10mL fill in 12mL syringe, Does not contain natural rubber latex or preservatives, Contents and its pathway are sterile, Single Use
10manufacturers in China registered for this device type
6catalogue numbers in this listing
4510(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 | Medefil, Inc., United States |
|---|---|
| FDA product code | NGT |
| Device type | Saline, Vascular Access Flush |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5200 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer |
| 510(k) | K091583 |
| Record published | 2016-04-21 |
| Record revised | 2018-11-22 (version 5) |
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, manufacturing date, serial number |
| Storage | Storage environment temperature 15 to 30 °C |
| Packaging | Box of 16, carton of 16 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 3mL in 6mL Syringe | 60 | In distribution | |
| 3mL in 12mL Syringe | 60 | In distribution | |
| 2mL in 6mL Syringe | 60 | In distribution | |
| 5mL in 6mL Syringe | 60 | In distribution | |
| 5mL in 12mL syringe | 60 | In distribution | |
| 10mL in 12mL syringe | 60 | 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 |
| 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 |
|---|---|
| K121262 | 2012-09-20 |
| K091583 | 2010-01-28 |
| K020996 | 2002-06-24 |
| K020999 | 2002-06-20 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Mckesson Medical-Surgical Inc. Corporate Office | 510(k) number | 2022-05-25 | Class II | Environmental control | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21. | a. 20 Boxes b. 1 bx |
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.