Membrane Changer Set
The membrane and the electrolyte of SenTec TC Sensors must be changed periodically. For this purpose the old sensor membrane must be removed, the sensor surface must be cleaned, new…
The membrane and the electrolyte of SenTec TC Sensors must be changed periodically. For this purpose the old sensor membrane must be removed, the sensor surface must be cleaned, new electrolyte must be applied and a new sensor membrane must be put on. The patented Membrane Changer (MC-R) is a tool that allows the user to carry out the whole membrane change process by 4 simple press-and-turn steps. To enable an economic and cost saving membrane change, the Membrane Changer after use can be reloaded with a new Membrane Changer Insert (MC-I). The memrane changer set contains the MC-R and inserts (MC-I) to reload. Membrane Changer Set [1 membrane changer, 1 insert]
4manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Guangdong (2), Jiangsu (1), Sichuan (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
| Measurement Specialties Chengdu | Chengdu | Sichuan | Contract manufacturer | 3 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
Record
| Listed by | Sentec AG, Switzerland |
|---|---|
| FDA product code | DPZ |
| Device type | Oximeter, Ear |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2710 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K041548 |
| Record published | 2016-08-31 |
| Record revised | 2026-03-17 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: during transport: 0-50°C; Storage environment temperature 10 to 30 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MC-SET | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| TruSignal SpO2 | GE Healthcare Finland OY | 16 |
| Oximeter, Ear | GE Healthcare Finland OY | 9 |
| Ear sensor | Honeywell Healthcare Solutions GmbH | 8 |
| BCI | ICU Medical, Inc | 3 |
| TruSignal SpO2 | GE Medical Systems, LLC | 2 |
| 103164 tCOM+ | Sentec AG | 1 |
| Multi-Site Attachment Ring for mature/intact skin | Sentec AG | 1 |
| Sentec Digital Monitor | Sentec AG | 1 |
| Contact Gel | Sentec AG | 1 |
| 103421 Sensor Adapter Cable (Long) | Sentec AG | 1 |
| Digital Sensor Adapter Cable, 250 cm | Sentec AG | 1 |
| Non-Adhesive Wrap | Sentec AG | 1 |
Showing 12 of 40. All products under Oximeter, Ear
Recalls Naming This Product
14 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 |
|---|---|---|---|---|---|---|---|
| Sentec AG | 510(k) number | 2023-07-25 | Class II | Process control | During rework of components during the manufacturing process, an additional piece of material may have been left in the device, which may result in an impact on measurement performance. | REVISED 9/21/2023-15,065 packages | |
| Sentec AG | 510(k) number | 2023-05-02 | Class II | Device Design | The sensors may experience an out-of-box failure because after recalibration, the sensors stayed in the software mode “production” and were not reset to “released” mode. | 11 in the U.S. | |
| Sentec AG | 510(k) number | 2022-08-22 | Class II | Under Investigation by firm | Weak skin adhesion. | 17208 units | 2026-05-26 |
| Sentec AG | 510(k) number | 2020-12-10 | Class II | Device Design | Device requires the use of an Isolation Transformer in combination with the SDM in home care settings to comply with applicable safety standards. | 15 devices | 2026-08-31 |
| Sentec AG | 510(k) number | 2019-05-02 | Class II | Process control | There is an increased chance (approx. 5%) of no electrolyte or a reduced amount of electrolyte being applied to the sensor during the membrane change procedure. | 198 pcs. | 2020-12-16 |
| Sentec AG | 510(k) number | 2019-05-02 | Class II | Process control | There is an increased chance (approx. 5%) of no electrolyte or a reduced amount of electrolyte being applied to the sensor during the membrane change procedure. | 22 pcs | 2020-12-16 |
| Sentec AG | 510(k) number | 2019-05-02 | Class II | Process control | There is an increased chance (approx. 5%) of no electrolyte or a reduced amount of electrolyte being applied to the sensor during the membrane change procedure. | 10 pcs | 2020-12-16 |
| Sentec AG | 510(k) number | 2019-05-02 | Class II | Process control | There is an increased chance (approx. 5%) of no electrolyte or a reduced amount of electrolyte being applied to the sensor during the membrane change procedure. | 3 sets | 2020-12-16 |
| Sentec AG | 510(k) number | 2019-05-02 | Class II | Process control | There is an increased chance (approx. 5%) of no electrolyte or a reduced amount of electrolyte being applied to the sensor during the membrane change procedure. | 205 pcs | 2020-12-16 |
| Sentec AG | 510(k) number | 2016-09-15 | Class II | Component change control | Sentec AG found that with one batch of an internal SenTec Monitor component (Docking Station Module) there is a risk that a fastening screw could become loose under certain circumstances. A loose screw within the monitor can create uncontro | 75 (54 US; 21 =OUS) | 2017-06-23 |
| Sentec AG | 510(k) number | 2015-03-25 | Class II | Under Investigation by firm | SenTec is voluntarily replacing V-Sign Sensors 2 due to pre-mature deterioration of a part of the PCO2 measuring unit and thus disabling PCO2-monitoring. This means that the affected sensors reach their end-of-life earlier than normally exp | 129 US, 59 OUS | 2016-02-05 |
| Sentec AG | 510(k) number | 2012-11-05 | Class II | Component design/selection | A manufacturing defect was observed for the membrane changer insert that does not allow electrolyte to be present under the new membrane. The PCO2 performance of a sensor without electrolyte will be deteriorated. | 195 boxes (9 per box) | 2012-12-18 |
| Sentec AG | 510(k) number | 2012-11-05 | Class II | Component design/selection | A manufacturing defect was observed for the membrane changer insert that does not allow electrolyte to be present under the new membrane. The PCO2 performance of a sensor without electrolyte will be deteriorated. | 265 boxes (5 per box) | 2012-12-18 |
| Sentec AG | 510(k) number | 2012-07-09 | Class II | Device Design | SenTec is recalling a number of V-Sign”2 Sensors due to a problem regarding configuration parameter writing during manufacturing. | 8 | 2012-10-11 |
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.