CarboTrack
Carbon Dioxide Airway Adapter
2manufacturers in China registered for this device type
1catalogue number
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 | Jada Medical LLC, United States |
|---|---|
| FDA product code | PHS |
| Device type | Oral Airway Assist |
| Device class | Class 1 |
| Regulation | 21 CFR 868.5110 |
| Establishment | Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2021-02-19 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number |
| Storage | Handling environment temperature -30 to 60 °C |
| Packaging | 10 ea dispenser box of 10, case of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CT-001 | In distribution |
Same Product Code
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.