FDA UDI
In Commercial Distribution
🇺🇸 United States
Defibrillator Analyzer
DI: B3356500
·
Model: Delta 3000
·
NETECH CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Defibrillator Analyzer
- Primary DI
- B3356500
- Version / Model
- Delta 3000
- Catalog Number
- 650
- Company Name
- NETECH CORPORATION
- Labeler DUNS
- 177242153
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-06-16
- Public Version
- 4
- Public Version Date
- 2018-07-20
- Public Version Status
- Update
- Public Device Record Key
- ee096cc1-dbbc-4436-aedf-16a545e7aefb
Device Description
Delta 3000 is a full function defibrillator analyzer including Transcutaneous Pacemakers. In addition to the capability of testing all bi-polar defibrillators, it tests all Transcutaneous pacers, Atrial and Ventricular pacemakers. Delta 3000 is compact, light weight and easy to use. Among the functions include energy, peak voltage as well as cardio version, 10 lead ECG Arrhythmia waveform. Test results can be easily uploaded to a PC through the serial port.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- 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 | B3356500 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K961595 | 000 |