Portrait VSM
Portrait VSM ATO MODEL
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 | GE Medical Systems Information Technologies, Inc., United States |
|---|---|
| FDA product code | DPZ |
| Device type | Oximeter, Ear |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2710 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K233810 |
| Record published | 2024-05-05 |
| Record revised | 2024-11-28 (version 2) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Handling environment atmospheric pressure 70 to 106 KiloPascal; Storage environment atmospheric pressure 70 to 106 KiloPascal; Storage environment temperature -20 to 60 °C; Handling environment humidity 15 to 90 % RH; Storage environment humidity 10 to 90 % RH; Handling environment temperature 5 to 35 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MVC101 | 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
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| GE Healthcare Finland OY | UDI-DI | 2025-09-26 | Class II | Component change control | Potential loss of monitoring on affected monitors when powered by certain batteries. Affected batteries can lose capability to hold charge and provide back up power. If this situation occurs, it will cause loss of patient monitoring and pot | 5990 |
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.