FDA UDI
Not in Commercial Distribution
🇺🇸 United States
KODEX-EPD System
DI: 00884838095229
·
Model: 733015
·
Philips Medical Systems Nederland B.V.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- KODEX-EPD System
- Primary DI
- 00884838095229
- Version / Model
- 733015
- Company Name
- Philips Medical Systems Nederland B.V.
- Labeler DUNS
- 413819707
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-10-15
- Public Version
- 2
- Public Version Date
- 2023-09-26
- Public Version Status
- Update
- Public Device Record Key
- b6933bc5-edbc-45d4-a7cd-1158eab621b9
- Distribution End Date
- 2021-10-15
Device Description
The KODEX-EPD™ System is indicated for catheter-based cardiac electrophysiological (EP) procedures. The KODEX-EPD™ System provides information about the electrical activity of the heart and about catheter location during the procedure. The system can be used on patients who are eligible for a conventional electrophysiological procedure.
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
- 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 |
|---|---|---|---|---|
| DQK | Computer, Diagnostic, Programmable | Cardiovascular | 870.1425 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44783 | Cardiac mapping system application software | An individual software program or group of programs, routines and/or algorithms that add specific image processing and/or analysis capabilities to a cardiac mapping system computer for storing, processing and management of electronic information/data used to interpret cardiac physiology parameters. It is a basic set of application programs and routines used for cardiac mapping computer-controlled imaging which can be upgraded to correct programming errors or to add new system capabilities. An application program package is typically identified by a proprietary name and "version" or "upgrade" number. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00884838095229 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K180940 | 000 |