FDA UDI
In Commercial Distribution
🇺🇸 United States
Total ECG
DI: 00850033167177
·
Model: GMD50610001
·
GLOBALMEDIA GROUP, LLC
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Total ECG
- Primary DI
- 00850033167177
- Version / Model
- GMD50610001
- Catalog Number
- GMD50610001
- Company Name
- GLOBALMEDIA GROUP, LLC
- Labeler DUNS
- 103201849
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-12-08
- Public Version
- 2
- Public Version Date
- 2024-02-06
- Public Version Status
- Update
- Public Device Record Key
- 86c6e715-0870-4cda-822a-595c8713e60b
Device Description
ECG device incorporating a wireless 12-Lead ECG system, Windows®-based CardioVu software using the Glasgow 12-lead ECG analysis program, and a compact ECG acquisition device.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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 |
|---|---|---|---|---|
| DSI | Detector And Alarm, Arrhythmia | Cardiovascular | 870.1025 | 2 |
| MWJ | Electrocardiograph, Ambulatory (Without Analysis) | Cardiovascular | 870.2800 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 11413 | Electrocardiograph, professional, single-channel | A device intended to be used by a healthcare professional in a clinical setting to acquire and process the electrical activity of the heart for digital display in the form of a graph, to assist a physician in assessing electrical cardiac physiology [electrocardiography (ECG)]. It is designed for recording the electrical signal from only one configuration of electrodes (ECG-leads) at a time (single-channel). It will either include an integrated display or be designed to transmit ECG data to an off-the-shelf device for display; ECG electrodes may be included. Data interpretation and/or data telemetry features might also be included. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850033167177 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K181658 | 000 |