EasyMap MAP L (80mm)

Primary DI
04260192832124
Brand
EasyMap MAP L (80mm)
Company
MedFact Engineering GmbH
Model
MF0010
Catalog number
106-004
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.
Published
2026-01-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DRFCatheter, Electrode Recording, Or Probe, Electrode Recording

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DRFCatheter, Electrode Recording, Or Probe, Electrode RecordingCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K151139000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151139000EasyMap MAP CatheterMedfact Engineering GmbH2016-10-18DRF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260192832124PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260192832124042601928321244260192832124

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac mapping catheter, percutaneous, single-useA 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
341047635
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04260192830601EasyMap MAP M (70mm)MF0009106-0022026-01-30
04260192832131EasyMap MAP XL (90mm)MF0011106-0062026-01-30
24255650100406EasyConnect MAP CableMF0001104-0092026-01-30

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Primary DI, Brand, Company table
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00818087023061MAGiC SweepACCESS POINT TECHNOLOGIES, INC.DRF2026-05-15
00818087023085MAGiC SweepACCESS POINT TECHNOLOGIES, INC.DRF2026-05-15
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24255650100406EasyConnect MAP CableMedFact Engineering GmbHDRF2026-01-30
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