Device
The QMAPP GO, a basic hemodynamic monitoring system on wheels, is designed to help make examinations even more efficient, by housing all parameters in one amplifier and making oper...
Manufacturer
Fysicon B.V.
Fysicon B.V.
Model: QMAPP GO
Catalog: 01076110
DI: 08719689142162
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-19
Current Version: 2026-05-27
Description
The QMAPP GO, a basic hemodynamic monitoring system on wheels, is designed to help make examinations even more efficient, by housing all parameters in one amplifier and making operation intuitive (reporting functionalities) in order to optimize the workflow.
QMAPP GO contains all functionality’s you desire from a hemodynamic monitoring system placed on a trolley.
This gives the user the ability to use these functions everywhere.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
52ab5d66-e216-4723-942d-28fe0556a738
Distribution Status:
In Commercial Distribution
DUNS Number:
404866654
Device Count:
1
DM Exempt:
Yes
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
No
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
08719689142162
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 37807
Name: Cardiac catheterization monitoring system
Definition:
An assembly of devices designed to continuously obtain, amplify, and record various signals generated during procedures usually performed in the cardiac catheterization laboratory. It typically consists of a computerized central workstation including a monitor and a graphic recorder, and a slave monitor including patient interface modules in the catheterization laboratory. The system is used for procedures such as left heart catheterization, right heart catheterization ventriculograms, coronary angiography, and pacemaker insertions; also used in procedures intended for the determination of most haemodynamic characteristics, evaluation of therapies, and planning of surgical approaches.
FDA Product Codes
DQK
Computer, Diagnostic, Programmable
MWI
Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Premarket Submissions
Submission Number:
K241766
Supplement Number:
000