Labware, Assisted Reproduction, Exempt

FDA classification

FDA Class 2 ·Labware, Assisted Reproduction, Exempt

EV1000

FDA UDI

Edwards Lifesciences LLC·00690103193473·PRESSURE CONTROLLER KIT

EV1000

FDA UDI

Edwards Lifesciences LLC·00690103193374·HEART REFERENCE SENSOR

Medline International France

Authorized representative

🇫🇷 France·3 Manufacturers

StO2 algorithm, HemoSphere ForeSight Oximeter cable

FDA registration

EDWARDS LIFESCIENCES LLC·7 products·🇺🇸 United States

HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight

FDA registration

BECTON, DICKINSON AND COMPANY·7 products·🇺🇸 United States

Amphenol Medical Technologies (Dongguan) Co., Ltd.

FDA registration

Amphenol Medical Technologies (Dongguan) Co., Ltd.·8 products·🇨🇳 China

HemoSphere

FDA registration

EDWARDS LIFESCIENCES TECHNOLOGY SARL·8 products·🇺🇸 United States

Acumen Assisted Fluid Management

FDA registration

EDWARDS LIFESCIENCES LLC·8 products·🇺🇸 United States

HemoSphere ForeSight Oximeter Cable

FDA registration

EDWARDS LIFESCIENCES TECHNOLOGY SARL·8 products·🇺🇸 United States

HemoSphere Pressure Cable

FDA registration

BECTON, DICKINSON AND COMPANY·8 products·🇺🇸 United States

HemoSphere

FDA registration

EDWARDS LIFESCIENCES LLC·8 products·🇺🇸 United States

HemoSphere

FDA registration

CCT Critical Care Technologies, S.R.L. Also Trading As Edwards Lifesciences AG·8 products·🇩🇴 Dominican Republic

HemoSphere ForeSight Oximeter Cable

FDA registration

EDWARDS LIFESCIENCES LLC·8 products·🇺🇸 United States

HemoSphere

FDA registration

BECTON, DICKINSON AND COMPANY·8 products·🇺🇸 United States

Amphenol Cable and Interconnect Technologies Asia Pacific Ltd.

FDA registration

Amphenol Cable and Interconnect Technologies Asia Pacific Ltd.·8 products·🇭🇰 Hong Kong

HemoSphere ForeSight Oximeter Cable

FDA registration

CCT Critical Care Technologies, S.R.L. Also Trading As Edwards Lifesciences AG·8 products·🇩🇴 Dominican Republic

BENCHMARK ELECTRONICS, INC.

FDA registration

BENCHMARK ELECTRONICS, INC.·8 products·🇺🇸 United States

BENCHMARK ELECTRONICS San Jorge

FDA registration

BENCHMARK ELECTRONICS San Jorge·8 products·🇲🇽 Mexico

BENCHMARK ELECTRONICS, INC.

FDA registration

BENCHMARK ELECTRONICS, INC.·8 products·🇺🇸 United States