Resp-O2 Endotracheal Tube Introducer (Bougie), Adult, 15 FR
Catalogue number 36261, listed by Dynarex Corp., United States, under Bougie, Eustachian. 2 manufacturers in China are registered for this product code.
2manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Jiangsu (1), Shanghai (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Gcmedica Enterprise Ltd.(Wuxi) | Wuxi | Jiangsu | Contract manufacturer | 55 |
| Hitec Medical Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 17 |
Record
| Listed by | Dynarex Corp., United States |
|---|---|
| FDA product code | KBI |
| Device type | Bougie, Eustachian |
| Device class | Class 1 |
| Regulation | 21 CFR 874.4175 |
| Establishment | Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-05-16 |
| Record revised | 2024-10-09 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Master shipper of 20 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 36261 | 10 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Resp-O2 Endotracheal Tube Introducer (Bougie), Pediatric, 10 FR | Dynarex Corp. | 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.