NeoSeal®
The NeoSeal is intended to create a seal around the nares and protect the skin of the septum and nares. It is intended for use on pediatric (neonates, infants and children) patients.
Who Else Makes It
Concentrated in Guangdong (5), Jiangsu (4), Zhejiang (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 |
|---|---|---|---|---|
| Flexicare Medical (Dongguan) Ltd. | Dongguan | Guangdong | Contract manufacturer | 48 |
| Polymed (Xiamen) Plastic Industrial Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 17 |
| Intersurgical Medical Apparatus (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 12 |
| Flying Tooling Engineering Limited | Dongguan | Guangdong | Contract manufacturer | 9 |
| Ningbo Boya Medical Equipment Co., Ltd. | Yuyao | Zhejiang | Contract manufacturer | 8 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Ningbo Ningyuan Import & Export Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 80 |
| GaleMed (Xiamen) Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 33 |
| Shenzhen Xiazhifeng Electronic Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 25 |
| Suzhou Shangchuang Technology Service Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 23 |
| Dongguan Yipincheng Technology Co., Ltd. | Dongguan | Guangdong | Manufacturer | 17 |
| Shaoxing Undis Medical Technology Company Limited | Shaoxing | Zhejiang | Manufacturer | 17 |
Showing 12 of 17. All 17 manufacturers in China registered for Clip, Nose
Record
| Listed by | Neotech Products, LLC, United States |
|---|---|
| FDA product code | BXJ |
| Device type | Clip, Nose |
| Device class | Class 1 |
| Regulation | 21 CFR 868.6225 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2021-05-19 |
| Record revised | 2023-09-25 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| Small | 150 | In distribution | |
| Large | 150 | In distribution | |
| Micro | 150 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Curaplex | Bound Tree Medical, LLC | 6 |
| Noseclip | Vitalograph Ireland Ltd. | 6 |
| Jaeger | Jaeger Medical GmbH | 6 |
| Vyaire | Jaeger Medical GmbH | 4 |
| nSpire Health | Nspire Health, Inc. | 4 |
| Disposable Blue PFT Nose Clip with Rubber Pads | A-M Systems | 2 |
| Disposable PFT Nose Clip with Rubber Pads | A-M Systems | 2 |
| Noseclip, Disposable, White, Foam Pad | A-M Systems | 2 |
| Disposable Blue PFT Nose Clip with Foam Pads | A-M Systems | 2 |
| Nose Clip | Intersurgical Ltd. | 2 |
| Disposable PFT Nose Clip with Foam Pads | A-M Systems | 2 |
| Nose Clips | VectraCor, Inc. | 2 |
Showing 12 of 39. All products under Clip, Nose
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.