FDA UDI
In Commercial Distribution
🇺🇸 United States
Cardiac Function Laboratory
DI: 08717953256645
·
Model: CFL-M Inca
·
CD Leycom
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Cardiac Function Laboratory
- Primary DI
- 08717953256645
- Version / Model
- CFL-M Inca
- Catalog Number
- CDL001
- Company Name
- CD Leycom
- Labeler DUNS
- 414947457
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-09-20
- Public Version
- 1
- Public Version Date
- 2023-09-28
- Public Version Status
- New
- Public Device Record Key
- 9b731f6e-c3af-46ce-8e51-51a0495c568c
Device Description
Inca PV loop system for the measurement of cardiac function and performance.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- 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 |
|---|---|---|---|---|
| DQO | Catheter, Intravascular, Diagnostic | Cardiovascular | 870.1200 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46265 | Cardiac mapping system | An assembly of devices designed to measure, process, and store electronic 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, and catheters). The measurements can be compared to pre-established diagnostic criteria for parameters such as cardiac blood flow, electrical conduction, or heart chamber geometry. It typically consists of dedicated workstation, hardware and software that display real-time, three-dimensional (3-D) cardiac maps (e.g., electrical propagation, electrical potential, and cardiac chamber geometry maps), and a catheter. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08717953256645 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K003020 | 000 |