Device
Connection cable
Manufacturer
Fysicon B.V.
Model: QMAPP System cable blue for QMAPP Hybrid (2500 cm) Catalog: 01077006 DI: 08720254542294 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
Connection cable
Sterilization
Device Sterile: No
Sterilization Prior To Use: No
Regulatory & Distribution
Record Status: Published
Version Number: 1
Record Key: f9db38ca-ce1e-4d74-9f5d-81aab88e2c83
Distribution Status: In Commercial Distribution
DUNS Number: 404866654
Device Count: 1
DM Exempt: No
Premarket Exempt: No
HCT/P: No
Kit: No
Combination Product: No
Lot/Batch Tracked: Yes
Serial Number Tracked: No
Manufacturing Date Tracked: Yes
Expiration Date Tracked: No
Donation ID Number Tracked: No
Labeled Contains NRL: No
Labeled No NRL: No
Identifiers
Device ID: 08720254542294
Type: Primary
Issuing Agency: GS1
GMDN
Code: 47487
Name: Electrical-only medical device connection cable, reusable
Definition:
A non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. This is a reusable device.
FDA Product Codes
DSA
Cable, Transducer And Electrode, Patient, (Including Connector)
Premarket Submissions
Submission Number: K241766
Supplement Number: 000