FDA UDI
In Commercial Distribution
🇺🇸 United States
CARDIOVIT CS-200 Excellence
DI: 07613365001105
·
Model: 3.920280
·
Schiller AG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- CARDIOVIT CS-200 Excellence
- Primary DI
- 07613365001105
- Version / Model
- 3.920280
- Catalog Number
- 3.920280
- Company Name
- Schiller AG
- Labeler DUNS
- 480868538
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-06-06
- Public Version
- 1
- Public Version Date
- 2023-06-14
- Public Version Status
- New
- Public Device Record Key
- 16475727-a65b-4038-8b4a-a9162ed2b968
Device Description
The CARDIOVIT CS-200 Excellence is a multichannel ECG device used for the recording, analysis and evaluation of ECG recordings. It is designed for indoor use and can be used for all patients of both sexes, all races, and all ages and is intended for use in hospitals, cardiologic units, out-patient clinical units, and general physicians offices.The diagnostic applications for which the CARDIOVIT CS-200 Excellence is intended is in the field of cardiac abnormalities in the general population, detecting acute myocardial ischemia, and infarction in chest pain patients.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- 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 | 07613365001105 | GS1 |
Customer Contacts
- Phone
- +41417664242
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K970879 | 000 |
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 95 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- 5 – 50 Degrees Celsius
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 50 – 106 KiloPascal