RightSpotpH®
Small Bore Indicator
1manufacturer
1catalogue number
Who Else Makes It
Registered in Hunan.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| RD Biomed (Changsha) Ltd. | Changsha | Hunan | Manufacturer | 1 |
Record
| Listed by | Rightbio/Metrics Inc. |
|---|---|
| FDA product code | JLL |
| Device type | Tubeless Analysis, Gastric Acidity |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1320 |
| Premarket notification | Exempt |
| Record published | 2018-11-10 |
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, expiry date |
| Storage | Special storage condition: Keep dry; Special storage condition: Keep away from sunlight; Storage environment temperature -40 to 125 °F; Storage environment temperature -40 to 52 °C |
| Packaging | Master case of 350, inner carton of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| RSSB001 | 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.