The Heart Sync Pediatric(infant) Radiotranslucent Multifunction Electrodes are indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable…
The Heart Sync Pediatric(infant) Radiotranslucent Multifunction Electrodes are indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single patient use only. The electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (noninvasive) cardiac pacemaker and the patient’s skin. The electrode is intended for use on pediatric patients whose weight is less than 10 kg (100 joules). When a patient requires defibrillation, cardioversion or external pacing, these electrodes will be applied to the patient and connected to the instrument. This device is intended for use on defibrillators whose output is classified as low power (360 joule maximum). Comparable with Philips Plug Style connector models of monophasic and bi-phasic defibrillators.
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.
Record
Regulatory record for Pediatric (infant), radiolucent, defib electrodes w/ Physio connector | Listed by | Heart Sync, LLC, United States |
| FDA product code | LDD |
| Device type | Dc-Defibrillator, Low-Energy, (Including Paddles) |
| Device class | Class 2 |
| Regulation | 21 CFR 870.5300 |
| Premarket notification | Exempt |
| Record published | 2016-08-31 |
| Record revised | 2023-02-20 (version 3) |
Specifications
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 |
| Storage | Storage environment temperature -20 to 40 °C; Storage environment temperature -4 to 104 °F |
| Packaging | Pack of 10 |
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.