Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3034603598

FEI Number

3034603598

Entity Name

ORDINATRUM HEALTH

City/State/Country

Tustin, CA, US

Establishment Address

2522 Chambers Rd Ste 216, Tustin, CA 92780, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Ordinatrum Health (Owner Number: 10092246)

Owner / Operator Contact Address

2522 Chambers Rd Ste 216, Tustin, CA 92780, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K220117

PMA Number

N/A

All Registered Proprietary Names

ARC Intensive Care Information System (ARC System)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OUG	Medical Device Data System	General Hospital	Class 1	880.6310	2024-12-17
MWI	Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.2300	2024-12-17

Official Correspondent

ALI OZTURK

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Ordinatrum Health

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
K071802	Mammendorfer Institut Fur Physik Und Medizin GmbH	TESLA GUARD, MODEL EFT G04	2007-11-09
K124061	Invivo Corporation	MRI PATIENT MONITORING SYSTEM (MODEL 865214)	2013-02-22
K101264	Remote Diagnostic Technologies , Ltd.	TEMPUS IC PROFESSIONAL PATIENT MONITOR	2010-05-11
K113105	Remote Diagnostic Technologies , Ltd.	TEMPUSIC PATIENT MONITOR	2011-12-15
K134014	Remote Diagnostic Technologies , Ltd.	TEMPUS PRO ACCESSORIES (ULTRASOUND & VIDEO LARYNGOSCOPE PROBE)	2014-08-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2015	Invivo Corporation	2	Philips Expression MR200 MRI Patient Monitoring System Model 866120
Z-0004-2023	Philips North America Llc	2	MR Patient Care Portal 5000 (Desktop Unit), Model Number 453564792561 This is a component of product number 866162.
Z-0011-04	GE Medical Systems Information Technologies	2	Power cord manufactured by ElectriCord Manufacturing Company , P/N 316579, used with DINAMAP Patient Monitors as Follows: DINAMAP PRO Series, DINAMAP PRO 1000 Monitor under both the Critikon and GE Medical Systems. The company name EliectriCord is on the power cord plug.
Z-0042-2015	Mckesson Information Solutions LLC	2	McKesson Cardiology" Hemo intended for complete physiological/hemodynamic monitoring, clinical data acquisition, medical image and data processing, and analytical assessment.
Z-2183-2011	Remote Diagnostic Technologies Ltd. The Old Coach House, The Av. Farleigh Wallop, Basingstoke Hampshire United Kingdom	2	TEMPUS IC PROFESSIONAL Patient Monitor, Part No. 00-1002, Manufactured by: Remote Diagnostics Technologies Ltd., The Old Coach House, Farleigh Wallop, Hants, UK RG25 2HT. Indicated for 3 Lead ECG monitoring and 12 Lead ECG recording, non-invasive blood pressure (NIBP), respiration, end-tidal C02 (ETCO 2), pulse oximetry (SP02) and tympanic temperature.

Similar Registrations

Registration Number	Establishment Name	Location
3026606276	KEY ASIC BERHAD	PETALING JAYA Selangor, MY
3043603319	MEDICARE TAGS LIMITED T/A MEDYTRAK	Galway, IE
3002725312	AMERICAN PORTWELL TECHNOLOGY, INC.	Fremont, CA, US
3007832484	JWP MANUFACTURING	Santa Clara, CA, US
3037966017	HEALTH DATA WORKS	Ponte Vedra Beach, FL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3034603598. Last updated year: 2026. Please use registration number 3034603598 when referencing this establishment in official correspondence.