Identity
- Trade Name
- Datrend FDA UDI
- Generic Name
- External defibrillator tester FDA UDI
- Device Name
- Phase3 is the first Defibrillator / Pacer Analyzer specifically designed to test Pulsed Multiphasic defibrillators. – tests Monophasic, Biphasic and Pulsed Multiphasic Defibrillators, AEDs and Transcutaneous Pacers – see www.datrend.com for complete information FDA UDI
- Model / Reference
- Phase3 FDA UDI
- Description
- Phase3 is the first Defibrillator / Pacer Analyzer specifically designed to test Pulsed Multiphasic defibrillators. – tests Monophasic, Biphasic and Pulsed Multiphasic Defibrillators, AEDs and Transcutaneous Pacers – see www.datrend.com for complete information FDA UDI
Identifiers
- Catalog Number
- 8000-440 FDA UDI
- Primary DI / UDI-DI
- B418PHASE380004400 FDA UDI
- 510(k) Number
- K062099 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
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: External defibrillator tester
Datrend by Datrend Systems, Inc. — 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
- Datrend Systems, Inc.
Sources (1)
- FDA UDI 976bd78c-bb0f-4295-b195-20205f049bb7 36 fields · synced May 30, 2026