Disposa-Hood
Large Infant Oxygen Hood, Large-Wide Neck
6manufacturers in China registered for this device type
8catalogue numbers in this listing
1510(k) clearance
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 | Utah Medical Products, Inc., United States |
|---|---|
| FDA product code | FOG |
| Device type | Hood, Oxygen, Infant |
| Device class | Class 1 |
| Regulation | 21 CFR 868.5700 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| Record published | 2020-06-04 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| Large Hood | 8 | In distribution | |
| Large Collar | 2 | In distribution | |
| Extra Large Hood | 6 | In distribution | |
| Small Hood | 12 | In distribution | |
| Medium Hood | 12 | In distribution | |
| Large-Wide Hood | 8 | In distribution | |
| Extra Large Collar | 2 | In distribution | |
| Small Collar | 2 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| Sea-Long Medical Hood | SEA-Long Medical Systems, LLC | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K792144 | 1979-12-05 |
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.