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AUTOMER, AUTOMER SET, AUTOPC/SISTEMA DE CALENTAMIENTO DE SANGRE Y FLUIDOS (AUTOMER, AUTOMER SET, AUTOPC) - INVIMA Registration 928587256f810c41f56175e252425fe0

Access comprehensive regulatory information for AUTOMER, AUTOMER SET, AUTOPC/SISTEMA DE CALENTAMIENTO DE SANGRE Y FLUIDOS (AUTOMER, AUTOMER SET, AUTOPC) (AUTOMER, AUTOMER SET, AUTOPC/BLOOD AND FLUID HEATING SYSTEM (AUTOMER, AUTOMER SET, AUTOPC)) in the Colombia medical device market through Pure Global AI's free database. This IIb medical device is registered under INVIMA analysis ID 928587256f810c41f56175e252425fe0 and manufactured by LM INSTRUMENTS S.A.. The device was registered on October 06, 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
IIb
928587256f810c41f56175e252425fe0
AUTOMER, AUTOMER SET, AUTOPC/SISTEMA DE CALENTAMIENTO DE SANGRE Y FLUIDOS (AUTOMER, AUTOMER SET, AUTOPC)
INVIMA Analysis ID: 928587256f810c41f56175e252425fe0
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Product Use / Uso del Producto
Spanish

ACE WARMING SYSTEM ESTÁ DISEÑADO PARA CALENTAR SANGRE, PRODUCTOS SANGUÍNEOS Y LÍQUIDOS PARA PREVENIR LA HIPOTERMIA DEL PACIENTE PARA UN FLUJO RÁPIDO Y DE RUTINA. EL ACE WARMING SYSTEM INCLUYE UNA UNIDAD DE CALENTAMIENTO, UN INFUSOR DE PRESIÓN AUTOMÁTICO Y UN EQUIPO DE ADMINISTRACIÓN DE SANGRE / FLUIDOS INTRAVENOSO DESECHABLE. EL ACE WARMING SYSTEM LL ESTÁ DISEÑADO PARA CALENDAR SANGRE, PRODUCTOS SANGUÍNEOS Y LÍQUIDOS Y ADMINISTRARLOS A VELOCIDADES DE FLUJO DE 0 A 30,000ML/HR. A ESTOS CAUDALES, EL DISPOSITIVO MANTIENE TEMPERATURAS DE SALIDA DE FLUIDO QUE OSCILAN ENTRE 37?C A 41?C. SE TARDA MENOS DE 1 A 2 MINUTOS EN CALENTARSE HASTA LA TEMPERATURA DEL PUNTO DE AJUSTE.

English

THE ACE WARMING SYSTEM IS DESIGNED TO HEAT BLOOD, BLOOD PRODUCTS, AND FLUIDS TO PREVENT PATIENT HYPOTHERMIA FOR RAPID, ROUTINE FLOW. THE ACE WARMING SYSTEM INCLUDES A HEATING UNIT, AN AUTOMATIC PRESSURE INFUSER, AND A DISPOSABLE INTRAVENOUS FLUID/BLOOD ADMINISTRATION EQUIPMENT. THE ACE WARMING SYSTEM LL IS DESIGNED TO HEAT BLOOD, BLOOD PRODUCTS, AND LIQUIDS AND ADMINISTER THEM AT FLOW RATES FROM 0 TO 30,000ML/HR. AT THESE FLOW RATES, THE DEVICE MAINTAINS FLUID OUTLET TEMPERATURES RANGING FROM 37? C AT 41°C. IT TAKES LESS THAN 1 TO 2 MINUTES TO HEAT UP TO SET POINT TEMPERATURE.

Device Classification
Risk Class / Clase de Riesgo
IIb
Product Type (Spanish)
MEDICO QUIRURGICOS
Product Type (English)
SURGICAL DOCTOR
Registration Information
Analysis ID
928587256f810c41f56175e252425fe0
Expire Date
October 06, 2033
Authorized Company / Fabricante
Name (Spanish)
LM INSTRUMENTS S.A.
Name (English)
LM INSTRUMENTS S.A.