EasyMap MAP XL (90mm) 106-006

GUDID 04260192832131

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.

MedFact Engineering GmbH

Cardiac mapping catheter, percutaneous, single-use

• Primary Device ID: 04260192832131
• NIH Device Record Key: 02b2967a-df43-4b76-9d74-3f4faa24ceef
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EasyMap MAP XL (90mm)
• Version Model Number: MF0011
• Catalog Number: 106-006
• Company DUNS: 341047635
• Company Name: MedFact Engineering GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260192832131 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151139

FDA Product Code

• DRF: Catheter, Electrode Recording, Or Probe, Electrode Recording

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-02-09
• Device Publish Date: 2026-01-30

Devices Manufactured by MedFact Engineering GmbH

• 04260192830601 - EasyMap MAP M (70mm): 2026-02-09 EasyMap MAP is a temporary quadropolar Catheter for recording monophasic action potentials and for intracardial pacing. Integrat
• 04260192832124 - EasyMap MAP L (80mm): 2026-02-09 EasyMap MAP is a temporary quadropolar Catheter for recording monophasic action potentials and for intracardial pacing. Integrat
• 04260192832131 - EasyMap MAP XL (90mm): 2026-02-09EasyMap 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.
• 04260192832131 - EasyMap MAP XL (90mm): 2026-02-09 EasyMap MAP is a temporary quadropolar Catheter for recording monophasic action potentials and for intracardial pacing. Integrat
• 24255650100406 - EasyConnect MAP Cable: 2026-02-09 EasyConnect MAP connection cables realize a safe, quick and interference-free connection of your MedFact MAP-Catheter (MagnoMap