Monoject
Monoject™ 0.9% Sodium Chloride Prefilled Flush Syringe, 10ML Fill, 12ML Syringe
10manufacturers in China registered for this device type
19catalogue numbers in this listing
3recalls on this 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 | Cardinal Health, United States |
|---|---|
| FDA product code | NGT |
| Device type | Saline, Vascular Access Flush |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5200 |
| Establishment | Contract manufacturer, Reprocessor, Contract steriliser, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K032438 |
| Record published | 2016-09-24 |
| Record revised | 2025-11-20 (version 11) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Keep dry;AVOID DIRECT SUNLIGHT |
| Packaging | Case of 180, pack_or_inner_pack of 30, pack_or_inner_pack of 100, case of 800, case of 6, pack_or_inner_pack of 20 |
| Sizes | Total volume 2.5 to 10 ml |
| Distribution end date | 2024-12-31 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 8881580123 | Total Volume 3 ml | In distribution | |
| 8881590123 | Total Volume 3 ml | In distribution | |
| 8881580121 | Total Volume 10 ml | In distribution | |
| 8881580125 | Total Volume 5 ml | In distribution | |
| 8881571300 | Total Volume 2.5 ml | 30 | In distribution |
| 8881571125 | Total Volume 5 ml | 30 | In distribution |
| 8881590125 | Total Volume 5 ml | In distribution | |
| 8881590121 | Total Volume 10 ml | In distribution | |
| 8881571121 | Total Volume 10 ml | 30 | In distribution |
| 8881570123 | Total Volume 3 ml | Withdrawn | |
| 8881579123 | Total Volume 10 ml | Withdrawn | |
| 8881570128 | Total Volume 10 ml | Withdrawn | |
| 8881570125 | Total Volume 5 ml | Withdrawn | |
| 8881570121D | Withdrawn | ||
| 8881570300 | Withdrawn | ||
| 8881579300 | Total Volume 10 ml | Withdrawn | |
| 8881570121 | Withdrawn | ||
| 8881579121 | Total Volume 10 ml | Withdrawn | |
| 8881579125 | Total Volume 10 ml | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Excelsior | Medline Industries, Inc. | 28 |
| AMSafe® Pre-Filled Normal Saline Flush Syringe | Amsino Medical Inc. | 25 |
| 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
Recalls Naming This Product
19 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 |
|---|---|---|---|---|---|---|---|
| Windstone Medical Packaging, Inc. | 510(k) number | 2021-08-19 | Class I | Device Design | Monoject 0.9% Sodium Chloride Flush Syringe Manufactured by Cardinal Health and placed into kits. Potential for the plunger to draw back after air has been expelled and reintroduce air back into the syringe. | 9,378 | |
| Cardinal Health | 510(k) number | 2021-08-04 | Class I | Device Design | Potential for the plunger to draw back after the air has been expelled and reintroduce air back into the syringe. | 267,217,860 eaches in total | |
| Cardinal Health | 510(k) number | 2021-08-04 | Class I | Device Design | Potential for the plunger to draw back after the air has been expelled and reintroduce air back into the syringe. | 267,217,860 eaches in total | |
| Cardinal Health | 510(k) number | 2021-08-04 | Class I | Device Design | Potential for the plunger to draw back after the air has been expelled and reintroduce air back into the syringe. | 267,217,860 eaches in total | |
| Covidien | 510(k) number | 2013-08-16 | Class II | Process control | Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin | 3,235,860 units | 2015-10-21 |
| Covidien | 510(k) number | 2013-08-16 | Class II | Process control | Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin | Unknown | 2015-10-21 |
| Covidien | 510(k) number | 2013-08-16 | Class II | Process control | Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin | Unknown | 2015-10-21 |
| Covidien | 510(k) number | 2013-08-16 | Class II | Process control | Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin | Unknown | 2015-10-21 |
| Covidien | 510(k) number | 2013-08-16 | Class II | Process control | Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin | Unknown | 2015-10-21 |
| Covidien | 510(k) number | 2013-08-16 | Class II | Process control | Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin | Unknown | 2015-10-21 |
| Covidien | 510(k) number | 2013-08-16 | Class II | Process control | Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin | Unknown | 2015-10-21 |
| Covidien | 510(k) number | 2013-08-16 | Class II | Process control | Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin | Unknown | 2015-10-21 |
| Covidien | 510(k) number | 2013-08-16 | Class II | Process control | Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin | 330,120 units | 2015-10-21 |
| Covidien | 510(k) number | 2010-11-15 | Not classified | Material/Component Contamination | The heparin sodium USP used to manufacture was produced with crude heparin containing Over-Sulfated Chondroitin Sulfate. | 54,000 | 2015-12-04 |
| Covidien | 510(k) number | 2010-11-15 | Not classified | Material/Component Contamination | The heparin sodium USP used to manufacture was produced with crude heparin containing Over-Sulfated Chondroitin Sulfate. | 329,520 | 2015-12-04 |
| Covidien | 510(k) number | 2010-11-15 | Not classified | Material/Component Contamination | The heparin sodium USP used to manufacture was produced with crude heparin containing Over-Sulfated Chondroitin Sulfate. | 1,356,480 | 2015-12-04 |
| Covidien | 510(k) number | 2010-11-15 | Not classified | Material/Component Contamination | The heparin sodium USP used to manufacture was produced with crude heparin containing Over-Sulfated Chondroitin Sulfate. | 52,920 | 2015-12-04 |
| Covidien | 510(k) number | 2010-11-15 | Not classified | Material/Component Contamination | The heparin sodium USP used to manufacture was produced with crude heparin containing Over-Sulfated Chondroitin Sulfate. | 178,200 | 2015-12-04 |
| Covidien | 510(k) number | 2010-11-15 | Not classified | Material/Component Contamination | The heparin sodium USP used to manufacture was produced with crude heparin containing Over-Sulfated Chondroitin Sulfate. | 1,539,540 | 2015-12-04 |
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.