2 Channel Ph Antimony, 21 Cm Spacing, 6.4 Fr
Catalogue number MMS-pH-21, listed by Medical Measurement Systems B.V., Netherlands, under Electrode, Ph, Stomach. 1 manufacturer in China is registered for this product code.
1manufacturer
1catalogue number
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 | Medical Measurement Systems B.V., Netherlands |
|---|---|
| FDA product code | FFT |
| Device type | Electrode, Ph, Stomach |
| Device class | Class 1 |
| Regulation | 21 CFR 876.1400 |
| Establishment | Exporter |
| 510(k) | K931963 |
| Record published | 2016-09-23 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Storage environment temperature 5 to 30 °C |
| Packaging | Pack of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MMS-pH-21 | 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 |
| 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, 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 Naming This Product
2 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Diversatek Healthcare Inc | 510(k) number | 2003-09-24 | Not classified | Other | Pouch containing pediatric probes was labeled as containing adult probes. | 17 probes | 2003-11-17 |
| Diversatek Healthcare Inc | 510(k) number | 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.