alpHaONE
Recorder for ph capsule
1manufacturer
4catalogue numbers in this listing
Who Else Makes It
Registered in Chongqing.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Chongqing Jinshan Science & Technology (Group) Co., Ltd. | Chongqing | Chongqing | Manufacturer | 4 |
Record
| Listed by | Chongqing Jinshan Science & Technology (Group) Co., Ltd., China |
|---|---|
| FDA product code | FFT |
| Device type | Electrode, Ph, Stomach |
| Device class | Class 1 |
| Regulation | 21 CFR 876.1400 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-01-23 |
| Record revised | 2023-01-05 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Handling environment temperature 5 to 45 °C; Handling environment atmospheric pressure 86 to 106 KiloPascal; Handling environment humidity up to 85 % RH |
| Packaging | Pack of 4, box of 5, pack of 2, pack of 5 |
| Distribution end date | 2033-06-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| JSPR-3 | In distribution | |
| JSPC-1 | In distribution | |
| JSPC-1 | In distribution | |
| JSPR-3 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Diversatek Healthcare | Diversatek Healthcare Inc | 36 |
| Versaflex | Given Imaging Ltd. | 35 |
| Bravo | Given Imaging Ltd. | 9 |
| Heidelberg pH Capsule System | Heidelberg Medical Inc | 7 |
| Restech | THE Reflux Company | 6 |
| Electrode, Ph, Stomach | Given Imaging Ltd. | 3 |
| Reflux | Given Imaging Ltd. | 2 |
| 2 channel pH antimony, 21 cm spacing, 6.4 Fr | Medical Measurement Systems B.V. | 1 |
| 2 channel pH antimony, 15 cm spacing, 6.4 Fr | Medical Measurement Systems B.V. | 1 |
| 2 channel pH antimony, 10 cm spacing, 6.4 Fr | Medical Measurement Systems B.V. | 1 |
| 1 channel pH antimony, 6.4 Fr | Medical Measurement Systems B.V. | 1 |
| Digitrapper | Given Imaging Ltd. | 1 |
Showing 12 of 14. All products under Electrode, Ph, Stomach
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.