Change Healthcare Cardiology
- Primary DI
- 17540262090017
- Company
- CHANGE HEALTHCARE ISRAEL LTD
- Model
- 14.1
- Published
- 2018-08-20
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- false
Related Records
Regulatory Flags
- DUNS number
- 600748180
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Identifiers
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 17540262090017 | Primary | GS1 | 0 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Package type | Contains DI | Discontinue date | Status |
|---|---|---|---|---|---|---|---|
| 17540262090017 | Primary | GS1 | 0 |
Product Codes
| Code | Name | Class | Specialty | Regulation | Implant | Malfunction reporting |
|---|---|---|---|---|---|---|
| LLZ | System, Image Processing, Radiological | 2 | Radiology | 892.2050 | N | Eligible |
Premarket Submissions
| Submission | Supplement |
|---|---|
| K181080 | 000 |
Premarket Details
GMDN Terms
| Term | Definition |
|---|---|
| Cardiology information system | A dedicated assembly of devices designed to electronically receive, collect, store, manage, assist in analysis of, display, output, and distribute data, within or between healthcare facilities, to support the administrative and clinical activities associated with the provision and utilization of cardiology services and facilities. The system consists of dedicated combined hardware (e.g., computers, terminals, network components) and software (typically embedded). |
Device Sizes
No records found.
Storage And Handling
No records found.
Sterilization Methods
| Method |
|---|
Contacts
No records found.
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 17540262120028 | Change Healthcare Cardiology ECG Mobile | 1.3 | 2019-04-15 | |
| 17540262090024 | Change Healthcare Cardiology | 14.1.1 | 2018-11-22 | |
| 17540262100020 | Change Healthcare Cardiology Hemo | 14.1.1 | 2018-11-22 | |
| 17540262110029 | Change Healthcare Cardiology ECG Management | 14.1.1 | 2018-11-22 | |
| 17540262100013 | Change Healthcare Cardiology Hemo | 14.1 | 2018-08-20 | |
| 17540262110012 | Change Healthcare Cardiology ECG Management | 14.1 | 2018-08-20 | |
| 17540262120011 | Change Healthcare Cardiology ECG Mobile | 1.2.4 | 2018-05-20 |