Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006073153

FEI Number

3006073153

Entity Name

SPECTRUM MEDICAL LTD

City/State/Country

GLOUCESTER Gloucestershire, GB

Establishment Address

Ashville Business Park, Commerce Road, GLOUCESTER Gloucestershire GL2 9SL, GB

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

SPECTRUM MEDICAL LTD (Owner Number: 9094087)

Owner / Operator Contact Address

Ashville Business Park, Commerce Road, Gloucester, GB-GLS GL2 9SL, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K210669

PMA Number

N/A

All Registered Proprietary Names

Quantum Elite 12" Workstation Quantum Elite 12 Quantum Centrifugal Drive QCD-37 Quantum Centrifugal Drive QCD-22 Quantum Micro-Cardioplegia Delivery Module Quantum Diagnostic Module 2 Quantum Diagnostic Module 1 SPECTRUM M2 MONITOR SPECTRUM M2 - M System Quantum Workstation VIPER M4 SPECTRUM M4 Quantum Smart Occluder Right Quantum Smart Occluder Left Quantum Workstation 12.1" Quantum Workstation 12.1 inch Quantum Mini Ventilation Module

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	2022-03-18
KFM	Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type	Cardiovascular	Class 2	870.4360	2020-04-14
DTR	Heat-Exchanger, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4240	2025-09-12
DRY	Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4330	2018-03-29
DWC	Controller, Temperature, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4250	2022-05-10
DRY	Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4330	2006-10-30
DRY	Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4330	2017-01-23
OUG	Medical Device Data System	General Hospital	Class 1	880.6310	2011-04-04
DRY	Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4330	2011-11-15
DTQ	Console, Heart-Lung Machine, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4220	2019-05-28
DRY	Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4330	2018-08-20
DTX	Gas Control Unit, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4300	2021-05-05

Official Correspondent

Asia Lukuc

US Agent Details

Cameron Schmitt Business: Spectrum Medical Inc. Email: cameron.schmitt@spectrummedical.com Phone: (803) 8333964

Related Public Records

Same Entity

SPECTRUM MEDICAL LTD

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
K001520	Alpha Omega, Inc.	ALPHA OMEGA DUAL COOLER-HEATER	2000-11-22

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.
Z-0035-2022	CardioQuip, LLC	2	CardioQuip, Modular Cooler-Heater, Model: MCH-1000(i), CE 2797, UDI: (01)00860000846103
Z-0036-2022	CardioQuip, LLC	2	CardioQuip, Modular Cooler-Heater 1000(i), Standard Unit, Model: MCH-10RMS, CE 2797, UDI: (01) 00860000846127
Z-0037-2022	CardioQuip, LLC	2	CardioQuip, Modular Cooler-Heater 1000(m),Compact Unit, Model:MCH-1000(m),CE 2797, UDI: (01)00860000846110
Z-0038-2022	CardioQuip, LLC	2	CardioQuip, Modular Cooler-Heater 1000(m),Thermoelectric Cooling Lid, Model: MCH-11TEC,CE 2797, UDI: (01) 00860000846134

Similar Registrations

Registration Number	Establishment Name	Location
1828100	TERUMO CARDIOVASCULAR SYSTEMS CORPORATION	ANN ARBOR, MI, US
1124841	TERUMO CARDIOVASCULAR SYSTEMS CORPORATION	ELKTON, MD, US
1118880	TERUMO MEDICAL CORP.	ELKTON, MD, US
9611109	LivaNova Deutschland GmbH	MUNCHEN Bavaria, DE
3002807090	Sterigenics Germany GmbH	Wiesbaden Hesse, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006073153. Last updated year: 2026. Please use registration number 3006073153 when referencing this establishment in official correspondence.