External Pacemaker Ananlyzer
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Basic Information
- Brand Name
- External Pacemaker Ananlyzer
- Primary DI
- B3359500
- Version / Model
- EXPMT 2000
- Catalog Number
- 950
- 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
- 7132e39e-e704-4618-bee4-99f5f522293b
Device Description
The EXPMT 2000 will test and verify all the functions of any External Pacemaker including, transcutaneous and Atrial and Ventricular sequential pacemakers. Operation of the analyzer is menu driven via eight tactile keys and a large four line LCD display. Test measurements are simultaneously presented on the display. Five ECG snaps are standard along with an RS-232 serial port that allows for printing both a heading and test measurements on a separate printer. Information may also be sent to an external device. The external test load has twelve user-selectable loads from 100 to 1000 Ohms for use with transcutaneous pacemakers.
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 |
|---|---|---|---|---|
| DTC | Analyzer, Pacemaker Generator Function | Cardiovascular | 870.3630 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 31700 | External pacemaker analyser | An electronic instrument designed to test an external pacemaker to ensure compliance with performance specifications. The device connects to the output of the pacemaker to test any or all of the pulse generator's parameters including pulse duration, pulse amplitude, pulse rate, and sensing threshold. The device may be used to test the function of an external pacemaker 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 | B3359500 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K961582 | 000 |