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Device Explorer · FDA GUDID · GMDN 57967

Medical equipment clinical data interfacing software

An application software designed for transportation, calculation, aggregation and derivation of data between patient connected medical devices and external information systems used in clinical settings for automating data collection and clinical information ma

US‑registered devices235in commercial distribution
Companies38labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription72%Rx‑only share
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Share of device records

Respironics, Inc.11449%
Abbott Rapid Diagnostics Informatics, Inc.146%
Medical Informatics Corp.115%
Siemens Healthcare Diagnostics Inc.94%
Spacelabs Healthcare (Washington), Inc94%
Seca Gmbh & Co. Kg73%
Kestra Medical Technologies, Inc.73%
Icare Finland Oy42%

Top labelers

CompanyDevicesShare
Respironics, Inc.11449%
Abbott Rapid Diagnostics Informatics, Inc.146%
Medical Informatics Corp.115%
Siemens Healthcare Diagnostics Inc.94%
Spacelabs Healthcare (Washington), Inc94%
Seca Gmbh & Co. Kg73%
Kestra Medical Technologies, Inc.73%
Icare Finland Oy42%
Philips Medizin Systeme Böblingen Gmbh42%
Philips Medical Systems Hsg42%
Eko Health, Inc.42%
Iem Gmbh31%

Company = labeler of record on GUDID. 38 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Vivo 45 LSVivo 50, VIvo 65αCare SENSNorav 1200 Series PC-ECGiCare PATIENT2Icare EXPORTIcare CLINICAQUREVisensiaFUKUDA DENSHIIEM GmbHAccu-Chek Careseca analytics 125seca 452seca connect 103Hillrom

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

FDA product codes

CodeNameDevices
BZDVENTILATOR, NON-CONTINUOUS (RESPIRATOR)110
MNSVENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING94
MNTVentilator, continuous, minimal ventilatory support, facilit70
CBKVENTILATOR, CONTINUOUS, FACILITY USE46
NOUCONTINUOUS, VENTILATOR, HOME USE45
MNTVENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY41

GMDN & GCC registration

  • GMDN code 57967 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 72% · 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

No structured size data on the register.

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

No closely related category with 50+ devices.

How many medical equipment clinical data interfacing software products are registered in the US?

235 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Medical equipment clinical data interfacing software", from 38 companies. The largest labeler is Respironics, Inc. with 49% of records.

Which FDA product codes apply?

BZD (VENTILATOR, NON-CONTINUOUS (RESPIRATOR)), MNS (VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING), MNT (Ventilator, continuous, minimal ventilatory support, facilit), CBK (VENTILATOR, CONTINUOUS, FACILITY USE)

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.

How do I get quotes?

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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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