Amron Oxygen Treatment Hood
02 Vinyl Hood W/Optical Window, Neck Ring Assembly, Straps AND Untrimmed Silicone Neck Seal
6manufacturers in China registered for this device type
2catalogue numbers in this listing
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 | Amron International, Inc., United States |
|---|---|
| FDA product code | FOG |
| Device type | Hood, Oxygen, Infant |
| Device class | Class 1 |
| Regulation | 21 CFR 868.5700 |
| Establishment | Manufacturer |
| Record published | 2024-12-30 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 8891-03 | In distribution | |
| 8891-03S | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Disposa-Hood | Utah Medical Products, Inc. | 8 |
| Avanos | Avanos Medical, Inc. | 1 |
| Ecleris NIV Helmet | Ecleris SRL | 1 |
| Bite Block | Avanos Medical, Inc. | 1 |
| Sea-Long Medical Hood | SEA-Long Medical Systems, LLC | 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.