FDA UDI
In Commercial Distribution
🇺🇸 United States
EPstar Fixed Electrophysiology Catheter
DI: 00685447003748
·
Model: DCF-2-8-55-130
·
Baylis Médicale Cie Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- EPstar Fixed Electrophysiology Catheter
- Primary DI
- 00685447003748
- Version / Model
- DCF-2-8-55-130
- Company Name
- Baylis Médicale Cie Inc
- Labeler DUNS
- 249225954
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-08-30
- Public Version
- 4
- Public Version Date
- 2023-12-08
- Public Version Status
- Update
- Public Device Record Key
- 005d2954-8a13-4f25-b5e2-785befad6f1b
Device Description
8 electrodes; Electrode spacing: 5-5-5 mm
Device Characteristics
- Single Use
- Yes
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DRF | Catheter, Electrode Recording, Or Probe, Electrode Recording | Cardiovascular | 870.1220 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46355 | Cardiac mapping catheter, percutaneous, single-use | A sterile, steerable, flexible tube containing multiple electrodes that is introduced percutaneously into the heart chambers in order to transmit electrical impulses for electrophysiological diagnostic examinations, e.g., intracardiac sensing, endocardial recording, stimulation, temporary pacing for evaluation of cardiac arrhythmias, cardioversion (CV) of electrical arrhythmias or electrophysiology (EP) mapping of cardiac structures. It is typically made of plastic with embedded electrodes often of platinum (Pt), iridium, or a composite. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00685447003748 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 130 | Centimeter | |
| Catheter Gauge | 2 | French |