Defibrillator / Transcutaneous Pacemaker Analyzer
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Basic Information
- Brand Name
- Defibrillator / Transcutaneous Pacemaker Analyzer
- Primary DI
- B3356600
- Version / Model
- DELTA 3300
- Catalog Number
- 660
- Company Name
- NETECH CORPORATION
- Labeler DUNS
- 177242153
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-03-05
- Public Version
- 1
- Public Version Date
- 2020-03-13
- Public Version Status
- New
- Public Device Record Key
- 8c1daa41-8de1-4f44-ba9d-212f9ae61d52
Device 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).
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DRL | Tester, Defibrillator | Cardiovascular | 870.5325 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36791 | External defibrillator tester | An electronic instrument used to test an external defibrillator to ensure compliance with performance specifications. The device connects to the output of the defibrillator, typically via contact plates, and measures the energy delivered by the defibrillator into a standard resistive load; it may also perform transcutaneous pacemaker testing, provide waveform information, and execute other quality control procedures. The device may be used to test the function of an external defibrillator periodically, after repair, or for training purposes. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B3356600 | HIBCC |