Sea-Long Medical Hood
5000 Series Helmet
6manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Jiangsu (2), Hubei (2), Fujian (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Polymed (Xiamen) Plastic Industrial Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 17 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Nanjing J SUN Healthcare Co., Ltd. | Nanjing | Jiangsu | Repacker / relabeller | 56 |
| Ecollink NON-Woven Company Limited | Hongkong | Manufacturer | 14 | |
| Hubei Feiteng Protective Products Co., Ltd. | Xiantao | Hubei | Manufacturer | 14 |
| Wuhan Lucky Star NON Woven Products Co Ltd | Wuhan | Hubei | Repacker / relabeller | 13 |
Record
| Listed by | SEA-Long Medical Systems, LLC, United States |
|---|---|
| FDA product code | FOG |
| Device type | Hood, Oxygen, Infant |
| Device class | Class 1 |
| Regulation | 21 CFR 868.5700 |
| Establishment | Manufacturer |
| Record published | 2024-11-21 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ultraviolet Light |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 500 Seris Model | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Disposa-Hood | Utah Medical Products, Inc. | 8 |
| Amron Oxygen Treatment Hood | Amron International, Inc. | 2 |
| Avanos | Avanos Medical, Inc. | 1 |
| Ecleris NIV Helmet | Ecleris SRL | 1 |
| Bite Block | Avanos Medical, Inc. | 1 |
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.