EasyMap MAP L (80mm)
Basic Information
- Brand Name
- EasyMap MAP L (80mm)
- Primary DI
- 04260192832124
- Version / Model
- MF0010
- Catalog Number
- 106-004
- Company Name
- MedFact Engineering GmbH
- Labeler DUNS
- 341047635
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-01-30
- Public Version
- 1
- Public Version Date
- 2026-02-09
- Public Version Status
- New
- Public Device Record Key
- cb5167fa-3f68-4583-a46a-64cd9f3e4455
Device Description
EasyMap MAP is a temporary quadropolar Catheter for recording monophasic action potentials and for intracardial pacing. Integrated in the tip of the lead are a Silver-Chloride Electrode (AgCl), a Silver Electrode (Ag) and in addition two orthogonal placed Silver Electrodes (Ag). The catheter can be introduced and positioned in the required area with the means of a suitable guiding system. The catheter has a good torque and is deflectable. By pushing the distal part of the handle the catheter tip can be deflected without jerk and infinitely variable in a steady position. The deflection of the catheter tip is effected proportional to the movement of the distal part of the handle. The once reached position then remains stable. The size of the deflection depends on the different lengths of the flexible catheter tip.
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 | 04260192832124 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K151139 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius