NeilMed Sinus Rinse Refill Box
Sinus Rinse products contain pre-weighed and sealed salt-soda mixture packets/sachets. The Kit variants also contain a bottle assembly (bottle, cap and tube that is affixed to the cap). The…
Sinus Rinse products contain pre-weighed and sealed salt-soda mixture packets/sachets. The Kit variants also contain a bottle assembly (bottle, cap and tube that is affixed to the cap). The packets/sachets contain a defined ratio of sodium chloride and sodium bicarbonate that provides a pH balanced isotonic, solution the resulting saline solution is squirted through a bottle assembly designed at NeilMed Products, Inc. The Hypertonic Sinus Rinse is an extra strength saline solution, which delivers over twice the concentration of saline as Isotonic Sinus Rinse Products. It comes with premixed packets/sachets containing a mixture of sodium chloride and sodium bicarbonate sold in an individual box. After mixing one packet/sachet with 240mL of water in 240mL bottle, a 1.8% saline solution is produced. After mixing one packet/sachet with 480mL of water in 480mL bottle, a 0.9% saline solution is produced.
Who Else Makes It
Concentrated in Guangdong (10), Zhejiang (5), Jiangsu (4). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Wenzhou Zuoyou Medical Technoloyg Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 21 |
| Goodwood Medical Care Ltd | Dalian | Liaoning | Contract manufacturer | 19 |
| Dalian Rongbang Medical Healthy Devices Co Ltd | Dalian | Liaoning | Contract manufacturer | 15 |
| Beilun Plastech Inc | Ningbo | Zhejiang | Contract manufacturer | 13 |
| Foshan City Shunde Jiajun Plastic & Hardware Products Co Ltd | Foshan | Guangdong | Contract manufacturer | 11 |
| Shanghai NEO-Medical Import & Export Co., Ltd. | Shanghai | Shanghai | Exporter | 59 |
| Jiangsu Guangda Medical Material Group Co., Ltd. | Haian | Jiangsu | Contract manufacturer | 32 |
| Zhejiang Anji Huabu Industrial Co., Ltd. | Huzhou | Zhejiang | Contract manufacturer | 32 |
| Jiangsu Senwo Medical Technology Co., Ltd. | Nantong | Jiangsu | Contract manufacturer | 26 |
| Tonglu Wanhe Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 24 |
| Shenzhen Balinda Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 23 |
| Aimi Health Technology (Guangdong) Co., Ltd. | Dongguan | Guangdong | Manufacturer | 21 |
Showing 12 of 25. All 25 manufacturers in China registered for Applicator, Ent
Record
| Listed by | Neilmed Pharmaceuticals, Inc., United States |
|---|---|
| FDA product code | KCJ |
| Device type | Applicator, Ent |
| Device class | Class 1 |
| Regulation | 21 CFR 874.5220 |
| Establishment | Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-03-02 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Hypertonic, 70 Premixed Packets | In distribution | |
| Isotonic, 50ct Packets/Sachets | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Novo Surgical | Novo Surgical, Inc. | 10 |
| Integra® Jarit® | Integra LifeSciences Production Corporation | 9 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 8 |
| Dryswab | Medical Wire & Equipment Company (Bath), Ltd. | 5 |
| V. Mueller | Carefusion 2200, Inc. | 5 |
| Novo Surgical Inc. | Novo Surgical, Inc. | 5 |
| Aesculap | Aesculap AG | 4 |
| Integra® | Integra LifeSciences Production Corporation | 4 |
| Bausch + Lomb | Bausch & Lomb Incorporated | 4 |
| NeilMed Sinus Rinse | Neilmed Pharmaceuticals, Inc. | 3 |
| Applicator, Ent | Summit Medical LLC | 3 |
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 3 |
Showing 12 of 40. All products under Applicator, Ent
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2024-12-28 | Class II | Under Investigation by firm | Due to nasal spray stability failure for bioburden. | 89,312 |
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.