FDA UDI
Not in Commercial Distribution
🇺🇸 United States
HeartVista Cardiac Package
DI: B440HVCP030
·
Model: 030004
·
Heartvista, Inc.
Product Codes
1
GMDN Terms
3
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- HeartVista Cardiac Package
- Primary DI
- B440HVCP030
- Version / Model
- 030004
- Catalog Number
- HVCP
- Company Name
- Heartvista, Inc.
- Labeler DUNS
- 602748373
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-06-01
- Public Version
- 2
- Public Version Date
- 2022-06-10
- Public Version Status
- Update
- Public Device Record Key
- 894a5c2f-2e25-4235-9917-c49e02a37e73
- Distribution End Date
- 2022-06-09
Device Description
HeartVista Cardiac Package
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
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| LNH | System, Nuclear Magnetic Resonance Imaging | Radiology | 892.1000 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40828 | MRI system operation software | Mainframe or personal computer (PC) based operating system software (or firmware) specific to the central processing unit (CPU) incorporated into a magnetic resonance imaging (MRI) system configuration. This includes the software or firmware based programs and routines supplied by the computer manufacturer that drive a specific computer in the performance of its tasks and assists the operators, applications programmers and programs with various supporting functions. A proprietary name and a "version number" are commonly used to identify different operating system versions. | No | Active |
| 40872 | MRI system application software | An individual software program or group of programs, routines or algorithms that add specific image processing and/or analysis capabilities to a magnetic resonance imaging (MRI) system configuration. A basic set of applications programs and routines are included with such computer-controlled imaging systems and they can be upgraded to correct programming errors or to add new system capabilities. Some applications software programs or program packages must be combined with specific hardware or firmware configurations in order to function as intended. Applications program packages are typically identified by a proprietary name and "version" or "upgrade" number. | No | Active |
| 40970 | MRI system operator console | The primary control panel for a magnetic resonance imaging (MRI) system. Depending on the device configuration, it typically includes hardware and software that allows for image display, processing, analysis, archiving and retrieval. It is a component of a diagnostic MRI system and typically includes the capabilities to be interfaced with a picture archiving and communication system (PACS), a local area network (LAN), a radiology information system (RIS) or a hospital information system (HIS). It differs from the workstation by only containing the primary controls for the direct operation of the MRI system. It is located in the direct proximity of the MRI either freestanding or integrated. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B440HVCP030 | HIBCC |