EXTERNAL CARDIOVERSION DEFIBRILLATOR ELECTRODE PADS
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Basic Information
- Primary DI
- 08809435482632
- Basic UDI-DI Code
- B-08809435482632
- Reference
- CUA0508O
- Device Types
- None provided
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 2b
- Status
- On The Market
- Manufacturer
- CU Medical Systems, Inc.
Additional Description
The “Defibrillation Electrodes” (hereinafter Pads) are disposable defibrillation electrode pads designed for use with defibrillator manufactured by CU Medical Systems, Inc. They are used in the acquisition of electrocardiogram (ECG) and delivery of defibrillation shocks Using a pads attached to the chest, the defibrillator can apply electrical energy of max to the heart to remove ventricular fibrillation or ventricular tachycardia. The pads are for defibrillation use only. They are not designed for pacing, monitoring, or synchronized cardioversion. They are also disposable and for single use only.
CND Nomenclature Codes
| Code | Description |
|---|---|
| C020401 | EXTERNAL CARDIOVERSION DEFIBRILLATOR ELECTRODE PADS |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II (excluding section 4) | 9805-2017-CE-KOR-NA-PS Rev. 6.0 | DNV Product Assurance AS | Expired |
Available In Countries
Similar Devices
Other on-the-market devices with the same classification (Eu Md Class 2b) and regulation (EU MDD).