Schiller Temperature Sensor Connecting Cable
Temp LP 3.0 Mallinckrodt CC
9manufacturers in China registered for this device type
1catalogue number
4510(k) clearances naming this product code
1recall
Who Else Makes It
Concentrated in Guangdong (6), Jiangsu (1), Hebei (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
| Edan Instruments, Inc. | Shenzhen | Guangdong | Contract manufacturer | 56 |
| Shenzhen Comen Medical Instruments Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 24 |
| Contec Medical Systems Co., Ltd. | Qinhuangdao | Hebei | Manufacturer | 22 |
| Guangdong Biolight Meditech Co., Ltd. | Zhuhai | Guangdong | Manufacturer | 19 |
| Shanghai Draeger Medical Instrument Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 4 |
| General Meditech, Inc. | Shenzhen | Guangdong | Complaint-file establishment | 3 |
Record
| Listed by | Schiller AG, Switzerland |
|---|---|
| FDA product code | MHX |
| Device type | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1025 |
| Establishment | Contract manufacturer, Private-label distributor, Manufacturer, Exporter |
| 510(k) | K221056 |
| Record published | 2023-09-27 |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, manufacturing date |
| Storage | Handling environment temperature -10 to 50 °C; Storage environment temperature 5 to 50 °C; Storage environment humidity 10 to 95 % RH |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 2.310262 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Fukuda Denshi | Fukuda Denshi Co., Ltd. | 326 |
| Welch Allyn, Inc. | Welch Allyn, Inc. | 266 |
| Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | Nihon Kohden Corp. | 205 |
| Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | Nihon Kohden America, Inc. | 139 |
| Surveyor Central | Mortara Instrument, Inc. | 71 |
| Tempus Pro | Remote Diagnostic Technologies Ltd. | 44 |
| Surveyor S12 | Mortara Instrument, Inc. | 38 |
| Ultraview | Spacelabs Healthcare (Washington), Inc | 29 |
| Surveyor S19 | Mortara Instrument, Inc. | 26 |
| Vital Signs™ | AirLife Finland Oy | 23 |
| Patient Monitor | Edan Instruments, Inc. | 22 |
| Telemetry Accessories | Philips Medizin Systeme Böblingen GmbH | 21 |
Showing 12 of 589. All products under Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K221056 | 2023-07-06 |
| K101619 | 2010-11-12 |
| K053207 | 2006-05-19 |
| K012226 | 2002-04-08 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Schiller AG | 510(k) number | 2025-08-08 | Class II | Nonconforming Material/Component | Vital sign monitoring instrument may trigger an error message during blood pressures measurements, Specifically, when the initial inflation pressure is set in the high-pressure range. | 266 units |
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.