Automated External Defibrillator
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Basic Information
- Primary DI
- 06973107240027
- Basic UDI-DI Code
- B-06973107240027
- Reference
- PowerBeat X1
- Device Types
- None provided
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 2b
- Status
- On The Market
- Manufacturer
- ViVest Medical Technology Co., Ltd.
Additional Description
The PowerBeat Series Automated External Defibrillator (hereinafter called “PowerBeat Series Defibrillator”) is a portable device that is mainly used for first aid on patients with ventricular fibrillation (VF) which is the most common cause of sudden cardiac arrest(SCA), and certain ventricular tachycardias (VTs). It consists of a host, a non-rechargeable battery and disposable defibrillation pads. Depending on the different display, there are two models, PowerBeat X1 and PowerBeat X3, X1 uses LED light, graphic panel and voice prompt to guide the operator, while X3 uses color display, voice, animation and text prompt.
CND Nomenclature Codes
| Code | Description |
|---|---|
| Z12030503 | AUTOMATIC DEFIBRILLATORS |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II (excluding section 4) | G1 107512 0002 | TÜV SÜD Product Service GmbH | Expired |
Available In Countries
Similar Devices
Other on-the-market devices with the same classification (Eu Md Class 2b) and regulation (EU MDD).