Change Healthcare Cardiology ECG Management
- Primary DI
- 17540262110029
- Company
- CHANGE HEALTHCARE ISRAEL LTD
- Model
- 14.1.1
- Published
- 2018-11-22
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- false
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 |
|---|
| 17540262110029 | Primary | GS1 | 0 | |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Package type | Contains DI | Discontinue date | Status |
|---|
| 17540262110029 | Primary | GS1 | 0 | | | | |
Product Codes
| Code | Name | Class | Specialty | Regulation | Implant | Malfunction reporting |
|---|
| DQK | Computer, Diagnostic, Programmable | 2 | Cardiovascular | 870.1425 | N | Eligible |
Premarket Details
| Submission | Supplement | Device | Applicant | Decision date | Product code |
|---|
| K113515 | 000 | HORIZON CARDIOLOGY ECG MANAGEMENT | Mckesson Israel , Ltd. | 2012-03-16 | DQK |
GMDN Terms
| Term | Definition |
|---|
| Cardiac mapping system computer | A dedicated computer with software that is a component of a cardiac mapping system and is used to process and store electronic information/data for the interpretation of cardiac physiological parameters received from the output of connected measuring devices [e.g., body surface or intracardiac electrocardiograph (ECG) sensors/transducers]. The measurements can be compared to pre-established diagnostic criteria for parameters such as cardiac blood flow, electrical conduction, or heart chamber geometry. The device may display real-time cardiac maps in various formats (e.g., electrical propagation maps, electrical potential maps, and cardiac chamber geometry maps). |
Device Sizes
No records found.
Storage And Handling
No records found.
Contacts
No records found.
Other Devices From This Company
Other Devices Sharing Product Codes
| Primary DI | Brand | Company | Product code | Published |
|---|
| 17540262100143 | Change Healthcare Cardiology Hemo | Change Healthcare Canada Company | DQK | 2026-03-09 |
| 17540262110142 | Change Healthcare Cardiology ECG Management | Change Healthcare Canada Company | DQK | 2026-03-09 |
| 17540262170047 | Change Healthcare Cardiology Hemodynamics | Change Healthcare Canada Company | DQK | 2026-03-09 |
| 06944413849570 | Holter ECG and ABP System | Edan Instruments, Inc. | DQK | 2026-03-02 |
| 00195278343383 | CARESCAPE CENTRAL STATION | Ge Medical Systems Information Technologies, Inc. | DQK | 2026-02-11 |
| 00195278343512 | CARESCAPE CENTRAL STATION | Ge Medical Systems Information Technologies, Inc. | DQK | 2026-02-11 |
| 00851424007089 | VIVO | Catheter Precision, Inc. | DQK | 2026-02-03 |
| 00085142400710 | VIVO Positioning Patches | Catheter Precision, Inc. | DQK | 2026-02-03 |
| 00851424007119 | VIVO System | Catheter Precision, Inc. | DQK | 2026-02-03 |
| 05415067055613 | EnSite™ | ST. JUDE MEDICAL, INC. | DQK | 2026-01-08 |
| 05415067054883 | EnSite™ | ST. JUDE MEDICAL, INC. | DQK | 2025-12-19 |
| 00732094360295 | Welch Allyn, Inc. | WELCH ALLYN, INC. | DQK | 2025-12-18 |
| 05415067053435 | EnSite™ | ST. JUDE MEDICAL, INC. | DQK | 2025-12-17 |
| 05415067053503 | EnSite™ | ST. JUDE MEDICAL, INC. | DQK | 2025-12-17 |
| 05415067053510 | EnSite™ | ST. JUDE MEDICAL, INC. | DQK | 2025-12-17 |
| 05415067054968 | EnSite™ | ST. JUDE MEDICAL, INC. | DQK | 2025-12-17 |
| 05415067054975 | EnSite™ | ST. JUDE MEDICAL, INC. | DQK | 2025-12-17 |
| 05415067054982 | EnSite™ | ST. JUDE MEDICAL, INC. | DQK | 2025-12-17 |
| 05415067054999 | EnSite™ | ST. JUDE MEDICAL, INC. | DQK | 2025-12-17 |
| 05415067055217 | EnSite™ | ST. JUDE MEDICAL, INC. | DQK | 2025-12-17 |
| 05415067055224 | EnSite™ | ST. JUDE MEDICAL, INC. | DQK | 2025-12-17 |
| 05415067055231 | EnSite™ | ST. JUDE MEDICAL, INC. | DQK | 2025-12-17 |
| 05415067055248 | EnSite™ | ST. JUDE MEDICAL, INC. | DQK | 2025-12-17 |
| 00850012226291 | iMap 3D Mapping and Navigation System | Cardionxt Inc | DQK | 2025-12-10 |
| 05415067051219 | EnSite™ | ST. JUDE MEDICAL, INC. | DQK | 2025-12-08 |
| 05415067051288 | EnSite™ | ST. JUDE MEDICAL, INC. | DQK | 2025-12-08 |
| 03770019196069 | Volta AF-Xplorer II | SUBSTRATE HD | DQK | 2025-11-18 |
| 00763000998394 | N/A | MEDTRONIC, INC. | DQK | 2025-11-14 |
| 05415067051158 | EnSite™ | ST. JUDE MEDICAL, INC. | DQK | 2025-09-15 |
| 05415067051172 | EnSite™ | ST. JUDE MEDICAL, INC. | DQK | 2025-09-15 |