Trulink
Pkgd Cable,cardiac Outpu T,edwards,rohs
10manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Guangdong (6), Jiangsu (1), Hebei (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 |
| Linxens Healthcare (Tianjin) Co., Ltd. | Jinnan District | Tianjin | Contract manufacturer | 7 |
| 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 |
| Orantech Inc. | Shenzhen | Guangdong | Contract manufacturer | 40 |
| 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 |
| Shandong Corecare Technology Limited | Jinan | Shandong | Manufacturer | 2 |
Record
| Listed by | Statcorp, Inc., United States |
|---|---|
| FDA product code | DSI |
| Device type | Detector And Alarm, Arrhythmia |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1025 |
| 510(k) | K103142 |
| Record published | 2017-05-03 |
| Record revised | 2024-06-06 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Patient cables & ECG leadwires | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Trulink | Spacelabs Healthcare (Washington), Inc | 160 |
| Fukuda Denshi | Fukuda Denshi Co., Ltd. | 30 |
| Q-Tel RMS | Mortara Instrument, Inc. | 20 |
| Detector And Alarm, Arrhythmia | Philips Medical Systems Hsg | 20 |
| ECG Electrodes | Philips Medical Systems Hsg | 19 |
| Seeq™ | Medtronic, Inc. | 18 |
| Life Sensing Instruments, Inc. | Life Sensing Instruments, Inc. | 17 |
| NIBP Cuffs | Philips Medical Systems Hsg | 14 |
| Waveline EZ+ | Avante | 11 |
| BodyGuardian | Preventice Technologies, Inc. | 10 |
| BodyGuardian Kit | Preventice Technologies, Inc. | 8 |
| Waveline Pro+ | Avante | 7 |
Showing 12 of 112. All products under Detector And Alarm, Arrhythmia
Recalls Naming This Product
9 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 |
|---|---|---|---|---|---|---|---|
| Spacelabs Healthcare Ltd. | 510(k) number | 2026-03-26 | Class II | Process control | Due to a manufacturing issue (i.e. malfunctioning of electrical Leakage tester). | 57 | |
| Spacelabs Healthcare Ltd. | 510(k) number | 2026-02-27 | Class II | Component change control | Multi-parameter command module has a circuit board issue and when in Auto mode, Cardiac Output (CO) measurement may activate early, resulting in Bad Curve error with no CO measurement or Irregular Curve error with CO measurement not automat | 1790 | |
| Spacelabs Healthcare Ltd. | 510(k) number | 2023-04-12 | Class II | Component change control | Command modules will display the following when parameter processing is suspended, depending on software version: 1) Older versions will have waveforms present with no alarms, 2) Newer versions have waveforms absent with no alarms. This may | 1,088 | |
| Spacelabs Healthcare Ltd. | 510(k) number | 2016-07-01 | Class II | Vendor change control | The firm has received multiple reports of the Non-Invasive Blood Pressure (NIBP) parameter becoming non-functional with an associated message (No Reading). In addition, there is one of the following three error messages: Inflate Error, HW E | 3801 modules and 116 PCBAs & valves distributed in the US; 1 | 2017-05-22 |
| Spacelabs Healthcare Ltd. | 510(k) number | 2015-04-21 | Class II | Software design | Modules resetting. This failure mode happens when the Spacelabs Command Module is configured with the Masimo SpO2 option (-M), the Spacelabs Respiration option (-R) and the Masimo SpO2 PCBA, PN: 010-1136-02. With these two options and the M | 1973 units total (1345 modules in the US and 604modules inte | 2015-11-16 |
| Spacelabs Healthcare Ltd. | 510(k) number | 2015-04-17 | Class II | Software design | Ultraview SL Command Modules which were upgraded with the Masimo SpO2 Option, Model 91496-M was affected. Customer reported that during the time that the module is resetting (~10 seconds), monitoring of all parameters will be suspended. Up | 1999 units total (1932 in the US and 67 international) | 2015-11-13 |
| Spacelabs Healthcare Ltd. | 510(k) number | 2014-05-08 | Class II | Software Manufacturing/Software Deployment | A software anomaly causes temperature alarm limits to change to limits which are not physiologically possible and result in nuisance false positive alarms. | 64 devices | 2014-06-03 |
| Spacelabs Healthcare Ltd. | 510(k) number | 2011-11-03 | Not classified | Process change control | NIBP pump inside the Ultraview SL Command Module, Model 91496, became loose. The pump is suspended by the air hoses and electrical connections, but there can be enough movement to damage internal components and cause the module to fail. | 6722 units worldwide (3598 units in US and 3124 units outsid | 2012-09-19 |
| Spacelabs Healthcare Ltd. | 510(k) number | 2011-07-13 | Not classified | Software design | One Spacelabs Medical Ultraview SL Command Module, Model 91496, was removed from customer due to software error. | one unit | 2012-01-20 |
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.