Identity
- Trade Name
- Cardio Clear FDA UDI
- Generic Name
- External defibrillation electrode, adult, single-use FDA UDI
- Device Name
- RadioTransparent Defibrillation Electrodes, Anderson Connector, Leads Out FDA UDI
- Model / Reference
- LOCA502 FDA UDI
- Description
- RadioTransparent Defibrillation Electrodes, Anderson Connector, Leads Out FDA UDI
Identifiers
- Catalog Number
- LOCA502 FDA UDI
- Primary DI / UDI-DI
- 00814907020036 FDA UDI
- 510(k) Number
- K103159 FDA UDI
- FDA Product Code
- LDD FDA UDI
- GMDN Term
- External defibrillation electrode, adult, 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
No
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: External defibrillation electrode, adult, single-use
Cardio Clear by Cardio Medical Products, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as External defibrillation electrode, adult, single-use.
- Heartsync by Vermed — GRAPHIC CONTROLS ACQUISITION CORP · Class III
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- X SERIES MONITOR/DEFIBRILLATOR — Zoll Medical Corporation · Class III
- HeartStart Adult/Child Plus Pads — Philips Medical Systems Hsg · Class III
- Powerheart® Adult Defibrillation Pads — Zoll Medical Corporation · Class III
- Heartsync by Vermed — GRAPHIC CONTROLS ACQUISITION CORP · Class III
- Intellisense Adult Defibrillation Pads, CPR Device, Powerheart® G5 — Cardiac Science Corporation · Class III
- Intellisense Adult Defibrillation Pads, CPR Device, Powerheart® G5 — Zoll Medical Corporation · Class II
Cleared under the same submission
K103159 also covers:
- Cardio Clear — CARDIO MEDICAL PRODUCTS, INC.
- Cardio Clear — CARDIO MEDICAL PRODUCTS, INC.
- Cardio Clear — CARDIO MEDICAL PRODUCTS, INC.
- Cardio Clear — CARDIO MEDICAL PRODUCTS, INC.
- Cardio Clear — CARDIO MEDICAL PRODUCTS, INC.
- Cardio Clear — CARDIO MEDICAL PRODUCTS, INC.
- Cardio Clear — CARDIO MEDICAL PRODUCTS, INC.
- Cardio Clear — CARDIO MEDICAL PRODUCTS, INC.
- Cardio Clear — CARDIO MEDICAL PRODUCTS, INC.
- Cardio Clear — CARDIO MEDICAL PRODUCTS, INC.
- Cardio Clear — CARDIO MEDICAL PRODUCTS, INC.
- Cardio Clear — CARDIO MEDICAL PRODUCTS, INC.
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 |
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Manufacturer
- Manufacturer
- Cardio Medical Products, Inc.
Sources (1)
- FDA UDI 9cd10ebc-c6db-400a-9307-4aafdff3c733 37 fields · synced May 29, 2026