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Defibrillator / Transcutaneous Pacemaker Analyzer
FDA UDIClass II (US FDA UDI)
by Netech Corp.
Identity
- Trade Name
- Defibrillator / Transcutaneous Pacemaker Analyzer FDA UDI
- Generic Name
- External defibrillator tester FDA UDI
- Device Name
- The DELTA 3300 Defibrillator / Transcutaneous Pacemaker Analyzer is a precision instrument for testing defibrillators and external (Transcutaneous) Pacemakers. It combines the complete testing functions of a Defibrillator Tester, Transcutaneous Pacemaker Analyzer, and 12-Lead ECG / Arrhythmia Simulator into one compact, lightweight, and easy-to-use instrument. The Delta 3300 tests all Defibrillators including AEDs. It measures both monophasic and Bi-Phasic waveforms. It is compact, lightweight and easy to use. The test results can be saved in the internal memory and uploaded to the PC and printed using ProComPrint software (CD included with the unit). FDA UDI
- Model / Reference
- DELTA 3300 FDA UDI
- Description
- The DELTA 3300 Defibrillator / Transcutaneous Pacemaker Analyzer is a precision instrument for testing defibrillators and external (Transcutaneous) Pacemakers. It combines the complete testing functions of a Defibrillator Tester, Transcutaneous Pacemaker Analyzer, and 12-Lead ECG / Arrhythmia Simulator into one compact, lightweight, and easy-to-use instrument. The Delta 3300 tests all Defibrillators including AEDs. It measures both monophasic and Bi-Phasic waveforms. It is compact, lightweight and easy to use. The test results can be saved in the internal memory and uploaded to the PC and printed using ProComPrint software (CD included with the unit). FDA UDI
Identifiers
- Catalog Number
- 660 FDA UDI
- Primary DI / UDI-DI
- B3356600 FDA UDI
- FDA Product Code
- DRL FDA UDI
- GMDN Term
- External defibrillator tester FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.5325 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: External defibrillator tester
Defibrillator / Transcutaneous Pacemaker Analyzer by Netech Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Netech Corp.
Sources (1)
- FDA UDI 8c1daa41-8de1-4f44-ba9d-212f9ae61d52 34 fields · synced May 29, 2026