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CAPIOX OXIGENATORS/RESERVOIRSOXIGENADOR DE MEMBRANA CON FILTRO ARTERIAL INTEGRADO - INVIMA Registration 9b3b3469333ae1afaef6b6c620802eeb

Access comprehensive regulatory information for CAPIOX OXIGENATORS/RESERVOIRSOXIGENADOR DE MEMBRANA CON FILTRO ARTERIAL INTEGRADO (CAPIOX OXYGENATORS/RESERVOIRMEMBRANE OXYGENATOR WITH INTEGRATED ARTERIAL FILTER) in the Colombia medical device market through Pure Global AI's free database. This IIa medical device is registered under INVIMA analysis ID 9b3b3469333ae1afaef6b6c620802eeb and manufactured by TERUMO COLOMBIA ANDINA SAS. The device was registered on August 09, 2033.

This page provides complete registration details including product type (SURGICAL DOCTOR), authorised information, and regulatory compliance data from the official Colombia INVIMA medical device database. Pure Global AI offers free access to Colombia's complete medical device registry with bilingual Spanish/English support, helping global MedTech companies navigate INVIMA regulations efficiently.

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INVIMA Official Data
IIa
9b3b3469333ae1afaef6b6c620802eeb
CAPIOX OXIGENATORS/RESERVOIRSOXIGENADOR DE MEMBRANA CON FILTRO ARTERIAL INTEGRADO
INVIMA Analysis ID: 9b3b3469333ae1afaef6b6c620802eeb
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Product Use / Uso del Producto
Spanish

EL OXIGENADOR CAPIOX FX HA SIDO DISEÑADO PARA SU USO EN PACIENTES QUE NECESITEN SOMETERSE A UNA CIRUGÍA A CORAZÓN ABIERTO QUE REQUIERE UN BYPASS CARDIOPULMONAR. EL OXIGENADOR CAPIOX FX ESTÁ DISEÑADO PARA SU UTILIZACIÓN EN PROCEDIMIENTOS QUIRÚRGICOS QUE REQUIERAN "BYPASS" CARDIOPULMONAR EN PERÍODOS HASTA 6 HORAS. CON UN MODULO PARA INTERCAMBIO GASEOSO CON UN INTERCAMBIADOR DE CALOR Y UN FILTRO ARTERIAL INTEGRADO._x000D_ EL RESERVORIO RÍGIDO TAMBIÉN ESTÁ DISEÑADO PARA USARSE EN DRENADO VENOSO ASISTIDO POR VACÍO, EN DRENADO POSTOPERATIVO DEL PECHO Y EN PROCEDIMIENTOS DE AUTOTRANSFUSIÓN PARA RETORNAR LA SANGRE AL PACIENTE DE MANERA ASÉPTICA PARA RESTAURAR EL VOLUMEN DE SANGRE._x000D_ RECUBRIMIENTO DE SUPERFICIE DE CONTACTO CON LA SANGRE CON XCOATING MATERIAL BIOCOMPATIBLE APLICADO PARA REDUCIR LA ADHESIÓN PLAQUETARIA._x000D_ EL ?LTRO ARTERIAL INTEGRADO SIRVE PARA ?LTRAR PARTÍCULAS NO BIOLÓGICAS Y EMBOLIZANTES Y PARA FACILITAR LA RETIRADA DE EMBOLISMOS GASEOSOS DE LA SANGRE QUE ?UYE A TRAVÉS DE UN CIRCUITO DE BYPASS CARDIOPULMONAR.

English

THE CAPIOX FX OXYGENATOR HAS BEEN DESIGNED FOR USE IN PATIENTS WHO NEED TO UNDERGO OPEN-HEART SURGERY THAT REQUIRES CARDIOPULMONARY BYPASS. THE CAPIOX FX OXYGENATOR IS DESIGNED FOR USE IN SURGICAL PROCEDURES THAT REQUIRE CARDIOPULMONARY BYPASS FOR PERIODS OF UP TO 6 HOURS. WITH A GAS EXCHANGE MODULE WITH A HEAT EXCHANGER AND AN ARTERIAL FILTER INTEGRADO._x000D_ THE RIGID RESERVOIR IS ALSO DESIGNED FOR USE IN VACUUM-ASSISTED VENOUS DRAINAGE, POSTOPERATIVE CHEST DRAINAGE, AND AUTOTRANSFUSION PROCEDURES TO RETURN BLOOD TO THE PATIENT ASEPTICALLY TO RESTORE THE VOLUME OF SANGRE._x000D_ BLOOD CONTACT SURFACE COATING WITH XCOATING BIOCOMPATIBLE MATERIAL APPLIED TO REDUCE ADHESION PLAQUETARIA._x000D_ THE? INTEGRATED ARTERIAL LTRO IS USED FOR ? TO REMOVE NON-BIOLOGICAL PARTICLES AND EMBOLIZERS AND TO FACILITATE THE REMOVAL OF GASEOUS EMBOLISMS FROM THE BLOOD THAT ? UYE THROUGH A CARDIOPULMONARY BYPASS CIRCUIT.

Device Classification
Risk Class / Clase de Riesgo
IIa
Product Type (Spanish)
MEDICO QUIRURGICOS
Product Type (English)
SURGICAL DOCTOR
Registration Information
Analysis ID
9b3b3469333ae1afaef6b6c620802eeb
Expire Date
August 09, 2033
Authorized Company / Fabricante
Name (English)
TERUMO COLOMBIA ANDINA SAS