Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011560054

FEI Number

3011560054

Entity Name

ORGANOX LIMITED

City/State/Country

Oxford Oxfordshire, GB

Establishment Address

3500 John Smith Drive, Oxford Business Park, Oxford Oxfordshire OX4 2WB, GB

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

OrganOx Limited (Owner Number: 10084836)

Owner / Operator Contact Address

3500 John Smith Drive, Oxford Business Park South, Oxford, GB-OXF OX4 2WB, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K133658

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DRY	Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4330	2026-06-12

Official Correspondent

No official correspondent registered.

US Agent Details

Arielle Drummond Email: arielle.drummond@organox.com Phone: (973) 2162182

Related Public Records

Same Entity

OrganOx Limited

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
K234065	Terumo Cardiovascular Systems Corporation	CDI OneView Monitoring System	2024-04-25

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2017	Terumo Cardiovascular Systems Corporation	2	CDI H/S Cuvette The intended use for the CDI H IS Cuvette is as follows: The CDI H/S Cuvettes are intended for use with a CDI monitor during cardiopulmonary bypass procedures when continuous monitoring of blood hematocrit and oxygen saturation is desired.

Similar Registrations

Registration Number	Establishment Name	Location
1828100	TERUMO CARDIOVASCULAR SYSTEMS CORPORATION	ANN ARBOR, MI, US
3006073153	SPECTRUM MEDICAL LTD	GLOUCESTER Gloucestershire, GB
1124841	TERUMO CARDIOVASCULAR SYSTEMS CORPORATION	ELKTON, MD, US
1118880	TERUMO MEDICAL CORP.	ELKTON, MD, US
9611109	LivaNova Deutschland GmbH	MUNCHEN Bavaria, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011560054. Last updated year: 2026. Please use registration number 3011560054 when referencing this establishment in official correspondence.