Sentinel
Sentinel 10.0.1 Standalone Workstat Licence EN
10manufacturers in China registered for this device type
28catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (7), Shanghai (2), Jiangsu (1). 4 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 |
| Jabil Circuit (Shanghai) Ltd. | Shanghai | Shanghai | Contract manufacturer | 31 |
| Amphenol Alden Products Company | Shenzhen | Guangdong | Contract manufacturer | 24 |
| Dongguan Ergotron Precision Technology Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 2 |
| 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 BelterHealthMeasurementAndAnalysisTechnologyCo.,Ltd | Shenzhen | Guangdong | Manufacturer | 7 |
| Philips (China) Investment Co., Ltd. Philips Healthcare – Shanghai CDC | Shanghai | Shanghai | Specification developer | 6 |
| Shenzhen Carewell Electronics Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 2 |
Record
| Listed by | Spacelabs Healthcare (Washington), Inc |
|---|---|
| FDA product code | DQK |
| Device type | Computer, Diagnostic, Programmable |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1425 |
| Record published | 2021-05-10 |
| Record revised | 2024-10-09 (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, manufacturing date, serial number |
| Storage | Storage environment humidity 0 to 0 % RH; Storage environment temperature 0 to 0 °C |
| Distribution end date | 2024-09-27 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Sentinal 11 | In distribution | |
| 98200 | In distribution | |
| Sentinal 11 | In distribution | |
| Sentinal 11 | In distribution | |
| 98200 | In distribution | |
| Sentinal 11 | In distribution | |
| 98200 | In distribution | |
| 98200 | In distribution | |
| Sentinel 11 | In distribution | |
| Sentinal 11 | In distribution | |
| 98200 | In distribution | |
| Sentinal 11 | Withdrawn | |
| 98200 | Withdrawn | |
| Sentinal 11 | Withdrawn | |
| 98200 | Withdrawn | |
| Sentinal 11 | Withdrawn | |
| Sentinal 11 | Withdrawn | |
| Sentinal 11 | Withdrawn | |
| 98200 | Withdrawn | |
| Sentinal 11 | Withdrawn | |
| 98200 | Withdrawn | |
| 98200 | Withdrawn | |
| Sentinal 11 | Withdrawn | |
| Sentinal 11 | Withdrawn | |
| 98200 | Withdrawn | |
| 98200 | Withdrawn | |
| Sentinel 11 | Withdrawn | |
| 98200 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| EnSite™ | St. Jude Medical | 177 |
| Computer, Diagnostic, Programmable | St. Jude Medical | 57 |
| MediGuide™ | St. Jude Medical | 41 |
| AcQMap | Acutus Medical, Inc. | 38 |
| WorkMate Claris™ | St. Jude Medical | 35 |
| iLab Ultrasound Imaging System | Boston Scientific Corporation | 32 |
| Rhythmia™ Mapping System | Boston Scientific Corporation | 31 |
| Rhythmia HDx™ | Boston Scientific Corporation | 26 |
| EnSite Precision™ | St. Jude Medical | 23 |
| PathfinderSL | Spacelabs Healthcare (Washington), Inc | 22 |
| Labsystem™ PRO | Boston Scientific Corporation | 19 |
| Pathfinder SL | Spacelabs Healthcare (Washington), Inc | 16 |
Showing 12 of 228. All products under Computer, Diagnostic, Programmable
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 |
|---|---|---|---|---|---|---|
| Spacelabs Healthcare Ltd. | UDI-DI | 2025-09-16 | Class II | Software design | Due to two distinct issues: 1. During patient admission, patient demographic fields may default to those of a previously viewed patient. 2. Systems configured with Resting/Rhythm ECG functionality, under specific navigation conditions, tes | 142 |
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.