Patient Application Kit for Sensitive/fragile Skin
A combination of single-use products intended to attach the Sentec Sensors to conventional measurement sites, recommended for adult, pediatric and neonatal patients with sensitive/fragile…
A combination of single-use products intended to attach the Sentec Sensors to conventional measurement sites, recommended for adult, pediatric and neonatal patients with sensitive/fragile skin.
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 | 2021-09-26 |
| Record revised | 2026-03-17 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 10 to 27 °C; Storage environment humidity 40 to 60 % RH |
| Packaging | Box of 12 |
| Distribution end date | 2024-01-25 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PAK-SF | Withdrawn |
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.