Ecleris NIV Helmet
Catalogue number R00, listed by Ecleris SRL, Argentina, 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 | Ecleris SRL, Argentina |
|---|---|
| FDA product code | FOG |
| Device type | Hood, Oxygen, Infant |
| Device class | Class 1 |
| Regulation | 21 CFR 868.5700 |
| Establishment | Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-06-30 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, manufacturing date |
| Storage | Handling environment temperature 20 to 30 °C; Handling environment humidity 35 to 95 % RH; Handling environment atmospheric pressure 50 to 106 KiloPascal; Storage environment temperature -30 to 50 °C; Storage environment humidity 10 to 95 % RH; Storage environment atmospheric pressure 50 to 106 KiloPascal |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| R00 | 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 |
| 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.