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Device Explorer · FDA GUDID · GMDN 36005

MRI system synchronizer

A physiological monitoring unit used as a component of a diagnostic magnetic resonance imaging (MRI) system, that produces a signal which enables image formation or data collection to be synchronized with a specific measurable physiological parameter, e.g., th

US‑registered devices57in commercial distribution
Companies8labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription33%Rx‑only share
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Share of device records

Ivy Biomedical Systems, Inc.3256%
Lafayette Instrument Company, Inc.1425%
Northh Medical Gmbh47%
Mipm Mammendorfer Institut Für Physik Und Medizin Gmbh24%
Ge Medical Systems, L.L.C.24%
Nordicneurolab As12%
Philips Medizin Systeme Böblingen Gmbh12%
Philips Ds North America Llc12%

Top labelers

CompanyDevicesShare
Ivy Biomedical Systems, Inc.3256%
Lafayette Instrument Company, Inc.1425%
Northh Medical Gmbh47%
Mipm Mammendorfer Institut Für Physik Und Medizin Gmbh24%
Ge Medical Systems, L.L.C.24%
Nordicneurolab As12%
Philips Medizin Systeme Böblingen Gmbh12%
Philips Ds North America Llc12%

Company = labeler of record on GUDID. 8 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

SyncBoxGating Cable - Siemenssmart-syncMR Patient Care Universal Gating InterfacePneumograph - Non-Metallic 98in. TubingPneumograph Nonmetalic 135cm Strap"Pediatric Pneumograph - Non-Metallic w/89"" TubPneumograph - Non-Metallic 89in. TubingPneumograph - Non-Metallic 18' w/ConnectorPneumograph - Non-Metallic 14ft. TubingPneumograph - Non-Metallic 12' w/ConnectorPediatric Pneumograph - Non-Metallic w/10' TubinPneumograph - Non-Metallic 10ft. Tubing"PED NONMETAL PNEUMO 89"" LATEX FREE""PNEUMO NONMETALIC 89"" LATEX FREE"NONMETAL PNEUMO 12' LUER LATEX FREE

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
LNHSystem, Nuclear Magnetic Resonance Imaging38
IXOSynchronizer, Ecg / Respirator, Radiographic14
MWIMonitor, Physiological, Patient (Without Arrhythmia Detectio11
MWIMONITOR,PHYSIOLOGICAL,PATIENT(WITHOUT ARRHYTHMIA DETECTION O4
MWIMonitor, physiological, patient (without arrhythmia detectio3
IXOSynchronizer, ECG / respirator, radiographic1

GMDN & GCC registration

  • GMDN code 36005 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 33% · OTC 0%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Lumen/Inner Diameter (Millimeter) · 14Length (Inch) · 10Height (Inch) · 7Width (Inch) · 7Depth (Inch) · 7Weight (Pound) · 7

Use these as the dimensions to specify in a tender line.

How many mri system synchronizer products are registered in the US?

57 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "MRI system synchronizer", from 8 companies. The largest labeler is Ivy Biomedical Systems, Inc. with 56% of records.

Which FDA product codes apply?

LNH (System, Nuclear Magnetic Resonance Imaging), IXO (Synchronizer, Ecg / Respirator, Radiographic), MWI (Monitor, Physiological, Patient (Without Arrhythmia Detectio), MWI (MONITOR,PHYSIOLOGICAL,PATIENT(WITHOUT ARRHYTHMIA DETECTION O)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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