Diversatek Healthcare
Infused Single-Use Z/pH Probe (Internal Reference), Single pH (Esophageal) with LES Locator, Locator Port 6cm
1manufacturer
36catalogue numbers in this listing
2recalls on this code
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 | Diversatek Healthcare Inc, United States |
|---|---|
| FDA product code | FFT |
| Device type | Electrode, Ph, Stomach |
| Device class | Class 1 |
| Regulation | 21 CFR 876.1400 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-09-24 |
| Record revised | 2023-06-15 (version 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 | Storage environment temperature 5 to 30 °C |
| Sizes | Catheter gauge 5 to 6.9 Fr |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ZPI-BG-52 | Catheter Gauge 6.9 Fr | In distribution |
| PHI10 | Catheter Gauge 6.9 Fr | In distribution |
| ZAI-BL-56 | Catheter Gauge 6.9 Fr | In distribution |
| ZPN-BG-07 | Catheter Gauge 6.4 Fr | In distribution |
| PHI5 | Catheter Gauge 6.9 Fr | In distribution |
| ZIN-BS-51 | Catheter Gauge 6.4 Fr | In distribution |
| PHIS | Catheter Gauge 6.9 Fr | In distribution |
| ZPN-BS-50 | Catheter Gauge 6.4 Fr | In distribution |
| ZAN-BD-31 | Catheter Gauge 6.4 Fr | In distribution |
| PHN15 | Catheter Gauge 6.4 Fr | In distribution |
| ZPN-BG-07E | Catheter Gauge 6.4 Fr | In distribution |
| ZAI-BL-55 | Catheter Gauge 6.9 Fr | In distribution |
| ZPN-BG-57 | Catheter Gauge 6.4 Fr | In distribution |
| ZAN-BG-44E | Catheter Gauge 6.4 Fr | In distribution |
| PHN21 | Catheter Gauge 6.4 Fr | In distribution |
| PHNS-P | Catheter Gauge 5 Fr | In distribution |
| PHI15 | Catheter Gauge 6.9 Fr | In distribution |
| ZAI-BS-01E | Catheter Gauge 6.9 Fr | In distribution |
| ZAI-BS-01 | Catheter Gauge 6.9 Fr | In distribution |
| ZAI-BG-44E | Catheter Gauge 6.9 Fr | In distribution |
| ZAN-BS-01 | Catheter Gauge 6.4 Fr | In distribution |
| ZAI-BL-54 | Catheter Gauge 6.9 Fr | In distribution |
| CZAN-BT-62 | In distribution | |
| ZAN-BG-44 | Catheter Gauge 6.4 Fr | In distribution |
| ZAN-BS-01E | Catheter Gauge 6.4 Fr | In distribution |
| PHNS | Catheter Gauge 6.4 Fr | In distribution |
| ZPN-BS-46 | Catheter Gauge 6.4 Fr | In distribution |
| ZAI-BD-31 | Catheter Gauge 6.9 Fr | In distribution |
| ZPN-BS-46E | Catheter Gauge 6.4 Fr | In distribution |
| PHN10 | Catheter Gauge 6.4 Fr | In distribution |
| PHN5 | Catheter Gauge 6.4 Fr | In distribution |
| PHN10-P | Catheter Gauge 5 Fr | In distribution |
| ZIN-BS-45E | Catheter Gauge 6.4 Fr | In distribution |
| ZPI-BS-46 | Catheter Gauge 6.9 Fr | In distribution |
| ZAI-BG-44 | Catheter Gauge 6.9 Fr | In distribution |
| ZAN-BT-60 | Catheter Gauge 6.4 Fr | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Versaflex | Given Imaging Ltd. | 35 |
| Bravo | Given Imaging Ltd. | 9 |
| Heidelberg pH Capsule System | Heidelberg Medical Inc | 7 |
| Restech | THE Reflux Company | 6 |
| alpHaONE | Chongqing Jinshan Science & Technology (Group) Co., Ltd. | 4 |
| 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
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2003-09-24 | Not classified | Other | Pouch containing pediatric probes was labeled as containing adult probes. | 17 probes | 2003-11-17 |
| 2003-01-08 | Not classified | Other | Failure of the dry silver chloride reference, resulting in malfunction and a ‘Lead Off’ indication. | 6678 probes | 2003-04-16 |
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.