Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004009431

FEI Number

3004009431

Entity Name

GlobalMed Holdings, LLC

City/State/Country

Scottsdale, AZ, US

Establishment Address

15020 North 74th Street, Scottsdale, AZ 85260, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

GlobalMed Holdings, LLC (Owner Number: 10033888)

Owner / Operator Contact Address

15023 N 73rd Street, Scottsdale, AZ 85260, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

eNcounter Cloud TotalVitals TotalVitals Variable Polarizing Hood TotalVitals ClearProbe; Interson Seemore Ultasound Probe ClearProbe, Interson Simpli Series Ultrasound Probe TotalExam 3 TotalExam 2 Total Exam Oto Total Exam Lite

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2013-05-10
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2024-11-21
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2024-11-21
DSH	Recorder, Magnetic Tape, Medical	Cardiovascular	Class 2	870.2800	2024-11-21
MWI	Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.2300	2024-11-21
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2024-11-21
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2024-11-21
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2024-11-21
PEQ	Accessories To Examination Light	General Hospital	Class 1	880.6320	2013-07-15
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2024-11-23
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2024-11-23
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2024-11-23
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2020-08-10
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2020-08-10
KZF	Device, Medical Examination, Ac Powered	General Hospital	Class 1	880.6320	2010-10-14

Official Correspondent

Michael Johnson

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

GlobalMed Holdings, LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K080013	Agfa Healthcare Corporation	REGISTRATION AND FUSION	2008-01-17
K042221	Barco NV Barcoview	CORONIS 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM	2004-12-30
K092915	Cedara Software Corp.	CEDARA WEBACCESS, MODEL: 2.4	2010-06-23
K961871	Siemens Medical Solutions USA, Inc.	FLOUROSPOT T.O.P.	1996-07-31
K122260	Aycan Digitalsysteme GmbH	AYCAN MOBILE	2012-09-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0012-2022	GE Healthcare, LLC	2	Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system
Z-0023-2016	GE Healthcare	2	Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations.
Z-0030-2026	CHANGE HEALTHCARE CANADA COMPANY	2	Change Healthcare Radiology Solutions software version 14.2.2
Z-0032-2012	Philips Healthcare Inc.	2	MDC PACS - release R2.3 SP1 . Phillips Healthcare Andover, Massachusetts A software application that is used for receiving, managing, archiving, distributing and recording medical images onto portable digital media (including but not limited to Compact Disk and DVD).
Z-0033-2007	AGFA Corp.	2	IMPAX 5.2 Systems with CAD Capability (Computer Assisted Diagnosis)

Similar Registrations

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3017991646	CARDIOWISE, INC.	Fayetteville, AR, US
3007120336	GE Healthcare Magyarorszag Kft.	Budapest, HU
3036758981	TAEYOUNG SOFT	Gwacheon-si Gyeonggi, KR
3010956703	Visual Medica	Ciudad Autonoma Buenos Aires Buenos Aires, Ciudad Autonoma de, AR
3030088963	REBRAIN	PESSAC Gironde, FR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004009431. Last updated year: 2026. Please use registration number 3004009431 when referencing this establishment in official correspondence.