← Back to catalogue
Pediatric (infant), radiolucent, defib electrodes w/ Anderson connector
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Pediatric (infant), radiolucent, defib electrodes w/ Anderson connector FDA UDI
- Generic Name
- Electrode conductive skin pad, single-use FDA UDI
- Device Name
- 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 Anderson connectors adapted cable. FDA UDI
- Model / Reference
- PED-100 FDA UDI
- Description
- 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 Anderson connectors adapted cable. FDA UDI
Identifiers
- Catalog Number
- PED-100 FDA UDI
- Primary DI / UDI-DI
- 00854664006041 FDA UDI
- FDA Product Code
- LDD FDA UDI
- GMDN Term
- Electrode conductive skin pad, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.5300 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Electrode conductive skin pad, single-use
Pediatric (infant), radiolucent, defib electrodes w/ Anderson connector by Heart Sync Inc — Class II — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Electrode conductive skin pad, single-use.
- Medline — MEDLINE INDUSTRIES, INC. · Class II
- Defibrillation Electrodes — Tz Medical, Inc. · Class II
- AED Brands, LLC — AED BRANDS, LLC · Class III
- Defibrillation Electrodes — Tz Medical, Inc. · Class II
- Medline — MEDLINE INDUSTRIES, INC. · Class II
- Defibrillation Electrodes — Tz Medical, Inc. · Class II
- Defibrillation Electrodes — Tz Medical, Inc. · Class II
- MULTISTIM — COMPASS HEALTH BRANDS CORP. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Heart Sync Inc
Sources (1)
- FDA UDI 2751bb87-ed5a-4ec8-bb25-339d243c75bb 36 fields · synced Jun 8, 2026