Avanos
Catalogue number 23618, listed by Avanos Medical, Inc., United States, under Hood, Oxygen, Infant. 6 manufacturers in China are registered for this product code.
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 | Avanos Medical, Inc., United States |
|---|---|
| FDA product code | FOG |
| Device type | Hood, Oxygen, Infant |
| Device class | Class 1 |
| Regulation | 21 CFR 868.5700 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K830781 |
| Record published | 2020-02-05 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 23618 | 24 | 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 |
| 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.