Tempus LS-Manual
Tempus LS-Manual Paediatric Electrodes
3manufacturers in China registered for this device type
6catalogue numbers in this listing
5recalls on this code
Who Else Makes It
All of them in Guangdong. 3 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 |
| Amphenol Alden Products Company | Shenzhen | Guangdong | Contract manufacturer | 24 |
| EMI (Dongguan) Asia Limited | Dongguan | Guangdong | Contract manufacturer | 9 |
Record
| Listed by | Remote Diagnostic Technologies Ltd., United Kingdom |
|---|---|
| FDA product code | LDD |
| Device type | Dc-Defibrillator, Low-Energy, (Including Paddles) |
| Device class | Class 2 |
| Regulation | 21 CFR 870.5300 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K200849 |
| Record published | 2020-11-02 |
| Record revised | 2024-07-25 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Distribution end date | 2022-11-23 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 01-3023 | In distribution | |
| 01-3020 | In distribution | |
| 01-3021 | In distribution | |
| 01-3012 | Withdrawn | |
| 01-3022 | Withdrawn | |
| 01-3025 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Unipower | Unipower Corp. | 623 |
| Internal Handle | Zoll Medical Corporation | 89 |
| Vermed | Nissha Medical Technologies Limited | 47 |
| Cardio Clear | Cardio Medical Products, Inc. | 33 |
| Dc-Defibrillator, Low-Energy, (Including Paddles) | Fiab SPA | 20 |
| Dc-Defibrillator, Low-Energy, (Including Paddles) | Physio-Control, Inc. | 20 |
| R2 | ConMed Corporation | 17 |
| HeartStart | Philips Medical Systems Hsg | 9 |
| Anybattery | Anybattery, Inc | 6 |
| Vermed Defib Pads | Graphic Controls Acquisition Corporation | 5 |
| HeartStart | Philips Electronics North America Corporation | 4 |
| Heartsync by Vermed | Graphic Controls Acquisition Corporation | 4 |
Showing 12 of 29. All products under Dc-Defibrillator, Low-Energy, (Including Paddles)
Recalls Naming This Product
4 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 |
|---|---|---|---|---|---|---|---|
| Remote Diagnostic Technologies Ltd. | 510(k) number | 2024-10-28 | Class III | Labeling Change Control | Due to incorrect labels applied to devices during servicing. Labels contain the incorrect product name and CAT number. | ||
| Remote Diagnostic Technologies Ltd. | 510(k) number | 2024-05-09 | Class II | Labeling design | Simultaneous ECG measurements with multiple devices, including a manual defibrillator, on the same patient may cause electrical noise or interference, which may lead to distortions of the ECG signal; distortions may lead to no or ineffectiv | 1745 | |
| Remote Diagnostic Technologies Ltd. | 510(k) number | 2023-05-08 | Class II | Device Design | Defibrillator/pacemaker module (DPM) may encounter a problem causing communication from the Mainboard to the DPM to fail, leading to no or ineffective pacing with displayed error message “HW failure DPM”. | 1147 | |
| Remote Diagnostic Technologies Ltd. | 510(k) number | 2020-11-17 | Class II | Software design | A software error was detected within software version 1.3.4 for the Tempus LS device. When exiting pacer back into manual mode the pacer pulse wave may put the ECG calibration out of calibration. This software error may result in a delay in | 175 devices | 2023-12-12 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. 1 is recorded with the root cause “No Marketing Application”: the device was distributed without the premarket submission its class requires, a compliance finding rather than a defect. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2022-01-28 | Class II | No Marketing Application | Distribution of Defibrillators that are not approved or cleared for distribution US Market. | 2 | 2024-07-25 |
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.