FDA UDI
In Commercial Distribution
🇺🇸 United States
External Pacemaker Analyzer
DI: B33596020000
·
Model: Advance EXPMT 2000
·
NETECH CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- External Pacemaker Analyzer
- Primary DI
- B33596020000
- Version / Model
- Advance EXPMT 2000
- Catalog Number
- 960-2000
- Company Name
- NETECH CORPORATION
- Labeler DUNS
- 177242153
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-08-23
- Public Version
- 1
- Public Version Date
- 2024-09-02
- Public Version Status
- New
- Public Device Record Key
- 690cc994-4908-4f0e-8354-c4e5c3f44ec5
Device Description
The Advance EXPMT 2000 pacemaker analyzer is an advanced microprocessor based test instrument designed to accurately measure the output parameters of all external pacemakers, including both transthoracic and transcutaneous devices with recent upgrade to the software version .The instrument is easy to use via the menu structure presented on a large four line LCD display. Resulting measurements of the tests performed are simultaneously shown on the LCD display. The Advance EXPMT 2000 is compact, lightweight, and rugged. It may be operated with one 9 volt battery or with an optional AC adapter. A standard RS232 serial port allows for printing and storage of results with optional printers and PDAs.
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
- 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 |
|---|---|---|---|---|
| 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 | B33596020000 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K961582 | 000 |