103149 Calibration Gas
The Calibration Gas serves as calibration gas for the Sentec transcutaneous sensors that monitor tcPCO2 and/or tcPO2 (V-Sign™ Sensor 2 and OxiVenT™ Sensor). The Calibration Gas is for use…
The Calibration Gas serves as calibration gas for the Sentec transcutaneous sensors that monitor tcPCO2 and/or tcPO2 (V-Sign™ Sensor 2 and OxiVenT™ Sensor). The Calibration Gas is for use only with the Docking Station integrated in the tCOM+.
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) | K232516 |
| Record published | 2024-07-05 |
| Record revised | 2026-03-17 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature up to 50 °C; Special storage condition: Keep away from heat/sparks/open flames/hot surfaces. No smoking. Pressurized container: Do not pierce or burn, even afte |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 103149 | 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
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.