Identity
- Trade Name
- AED Battery Exchange (Models 9146-ABE, G5-ABE, 5070-ABE, FR3-ABE) FDA PMA
- Generic Name
- Automated external defibrillators (non-wearable) FDA PMA
Identifiers
- PMA Number
- P190013 FDA PMA
- FDA Product Code
- MKJ FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Legislation / Framework
- 21 CFR Part 870.5310 FDA PMA
- Regulation Number
- 870.5310 FDA PMA
- Advisory Committee
- Cardiovascular FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The DBP-1400-ABE and DBP-2003-ABE are replacement batteries designed for automated external defibrillators (non-wearable). These batteries supply power to AEDs during self-maintenance, automated diagnostics, and defibrillation, ensuring continuous functionality when integrated with compatible devices.
These batteries are supplied as single-use, non-sterile components and are intended for use with specific AED models, including Cardiac Science Powerheart G3, G5, Philips HeartStart OnSite/Home, and HeartStart FR3. They are classified as Class III devices under FDA regulations and are authorized under PMA number P190013. Compatibility is strictly limited to the listed AED models, as detailed in the specifications.
Frequently asked questions
Are these batteries reusable or single-use, and how should they be handled after installation?
These batteries are designed for **single-use only** and are not intended to be reused. Once installed in a compatible AED, they provide power for self-maintenance, diagnostics, and defibrillation until the device’s internal battery is depleted. After use, they should be disposed of according to local regulations for electronic waste or hazardous materials, as they contain lithium-ion components.
Which specific AED models are compatible with the DBP-1400-ABE and DBP-2003-ABE batteries?
These batteries are **strictly compatible** with the following AED models: Cardiac Science Powerheart G3 (models 9390A, 9390E, 9300A, 9300E), Powerheart G5 (models G5A-80A, G5A-80C, G5S-80A, G5S-80C), Philips HeartStart OnSite/Home (models M5066A, M5067A, M5068A), Philips HeartStart FRx (model 861304), and Philips HeartStart FR3 (models 861388, 861389). Always verify the AED’s model number before purchasing to ensure compatibility.
How are these batteries supplied, and do they require any special handling or storage conditions?
The batteries are supplied as **non-sterile, single-use components** in their original packaging. They should be stored in a **cool, dry place**, away from direct sunlight or extreme temperatures, to maintain optimal performance. Avoid exposure to moisture or physical damage, as this could compromise functionality. The packaging should remain intact until immediate use.
What is the regulatory pathway for these batteries, and how can I confirm their compliance?
These batteries are **Class III devices** authorized under **FDA PMA number P190013**, meaning they undergo rigorous pre-market approval. Compliance is confirmed through the PMA designation and the listed **product code MKJ** under FDA regulations (870.5310). Always reference the PMA number and manufacturer’s documentation to verify regulatory status before use.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P190013 | Class III | Active |
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Manufacturer
- Manufacturer
- AED Battery Exchange, LLC
Sources (1)
- FDA PMA P190013 23 fields · synced Sep 18, 2026