KARDIOSCREEN
Basic Information
- Brand Name
- KARDIOSCREEN
- Primary DI
- 00860003374917
- Version / Model
- 1612A-CL
- Company Name
- IMEDRIX INC.
- Labeler DUNS
- 117027624
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 17
- Record Status
- Published
- Publish Date
- 2024-01-11
- Public Version
- 1
- Public Version Date
- 2024-01-19
- Public Version Status
- New
- Public Device Record Key
- 9d821049-4520-4da2-b192-fb3261af8450
Device Description
KardioScreen is a portable and mobile device intended to acquire a resting, diagnostic ECG using surface electrodes from adult patients and pediatric patients age 14-21 years. The device is intended to be used by doctors and/or trained healthcare professionals in a hospital, medical professional's facility, clinic, physician's office or any medical outreach center. The device can acquire, display, analyze and print either 6-lead or 12-lead electrocardiograms which can be exported for external use. The recorded ECG signals can help users to analyze and diagnose heart disease, but the device is not meant as a sole means of diagnosis. Senior Virtual Health Device Details KS-A00104,KS-A00110,KS-A00111,KS-A00112,KS-A00115,KS-A00117,KS-A00122,KS-A00131,KS-A00133,KS-A00136,KS-A00138,KS-A00139,KS-A00142,KS-A00145,KS-A00148,KS-A00149,KS-A00150 KS Converter Details KS-CN-A00104,KS-CN-A00110,KS-CN-A00111,KS-CN-A00112,KS-CN-A00115,KS-CN-A00117,KS-CN-A00122,KS-CN-A00131,KS-CN-A00133,KS-CN-A00136,KS-CN-A00138,KS-CN-A00139,KS-CN-A00142,KS-CN-A00145,KS-CS-A00148,KS-CN-A00149,KS-CN-A00150 Cable Details CMP220113-003 202201130002,CMP220113-003 202201130017,CMP220110-004 202201140008,CMP220110-004 202201140015,CMP220113-003 202201130026,CMP220113-003 202201130009,CMP220110-004 202201140023,CMP220113-003 202201130021,CMP220113-003 202201130022,CMP220113-003 202201130004,CMP220110-004 202201140018,CMP220113-003 202201130018,CMP220113-003 202201130010,CMP220110-004 202201140033,CMP220110-004 202201140027,CMP220113-003 202201130024,CMP220113-003 202201130001
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| DPS | Electrocardiograph | Cardiovascular | 870.2340 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16231 | Electrocardiograph, professional, multichannel | 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 two or more configurations of electrodes (ECG-leads) at a time (multichannel) and may be intended for resting ECG and/or stress/exercise ECG. 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 telemetry features might also be included. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860003374917 | GS1 | ||||
| Unit of Use | 00860003374900 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K191692 | 000 |