Curaplex
*Custom* Curaplex Children's Hospital Kit Orange Pouch
2manufacturers in China registered for this device type
3catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangxi (1), Jiangsu (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Rusun Medical Co., Ltd. | Yichun | Jiangxi | Manufacturer | 37 |
| Suzhou Shangchuang Technology Service Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 23 |
Record
| Listed by | Bound Tree Medical, LLC, United States |
|---|---|
| FDA product code | PHS |
| Device type | Oral Airway Assist |
| Device class | Class 1 |
| Regulation | 21 CFR 868.5110 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-03-31 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 8600-01491 | In distribution | |
| 8600-01495 | In distribution | |
| 8600-01494 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Grafco | GF Health Products, Inc | 10 |
| CarboTrack | Jada Medical 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.