EcoLite, Pediatric, Medium Concentration Oxygen Mask
Intersurgical EcoLite, pediatric, medium concentration oxygen mask with universal connector tube, 1.8m
Who Else Makes It
Concentrated in Zhejiang (40), Guangdong (29), Jiangsu (23). 24 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Rollmed Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 127 |
| Shanghai Joy Crown Industry Co., Ltd. | Pu Dong New Area | Shanghai | Contract manufacturer | 64 |
| Nanning Tecbod Biological Technology Co., Ltd. | Nanning | Guangxi | Contract manufacturer | 51 |
| Flexicare Medical (Dongguan) Ltd. | Dongguan | Guangdong | Contract manufacturer | 48 |
| Evereast Medical Products Group Co., Ltd. | Changyuan | Henan | Contract manufacturer | 30 |
| Vincent Medical (Dong Guan) Manufacturing Co., Ltd. | Dong Guan | Guangdong | Contract manufacturer | 29 |
| Ningbo Luke Medical Devices Co., Ltd. | Yuyao | Zhejiang | Contract manufacturer | 27 |
| Changzhou Recoo Healthcare Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 19 |
| Sunmed AP, Ltd. | Zhuhai | Guangdong | Contract manufacturer | 18 |
| Polymed (Xiamen) Plastic Industrial Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 17 |
| Hitec Medical Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 17 |
| Sunmed AP, Ltd., Warehouse NO. 2 | Zhuhai | Guangdong | Contract manufacturer | 16 |
Showing 12 of 126. All 126 manufacturers in China registered for Mask, Oxygen
Record
| Listed by | Intersurgical Ltd., United Kingdom |
|---|---|
| FDA product code | BYG |
| Device type | Mask, Oxygen |
| Device class | Class 1 |
| Regulation | 21 CFR 868.5580 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2023-06-13 |
| Record revised | 2025-02-11 (version 2) |
Specifications
| MRI safety | MR Safe |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Pack of 40 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 11906100 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Hudson RCI | Teleflex Medical LLC | 87 |
| Mask, Oxygen | Salter Labs | 61 |
| Curaplex | TRI-Anim Health Services, Inc. | 34 |
| 7301 EAGLE1 | Hans Rudolph, Inc. | 33 |
| Curaplex | Bound Tree Medical, LLC | 33 |
| Roscoe | Drive DeVilbiss Healthcare | 32 |
| BF | Allied Medical LLC | 28 |
| Ventlab | Ventlab, LLC | 25 |
| Adsafe™ | American Diagnostic Corp. | 25 |
| 7302 EAGLE2 | Hans Rudolph, Inc. | 24 |
| Oxygen Mask | Well Lead Medical Co., Ltd. | 24 |
| AirLife™ | Airlife, Inc. | 21 |
Showing 12 of 302. All products under Mask, Oxygen
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2017-04-03 | Class II | Nonconforming Material/Component | A defect in the wire-reinforced tubing may result in a partial of total occlusion when the cuff is over-inflated. | 144 cases / 20 units | 2019-06-17 |
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.