REDFLUID PEEP VALVE
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Portable Peep valve indicated as an accessory to provide positive and expiratory pressure breathing for Cpap and Ventilators. Two different male ISO inlets 20 and 30 mm. Pressure range 0 to 20 cmH2O as standard design Special pressures on demand up to 40 cmH20 for portable alveolar recruitment procedure. Válvula Peep portátil. Está indicada como accesorio para proporcionar respiración con presión positiva y espiratoria para Cpap y ventiladores.Dos entradas ISO macho diferentes de 20 y 30 mm. Rango de presión de 0 a 20 cm H2O como diseño estándarPresiones especiales bajo demanda de hasta 40 cmH20 para el procedimiento de reclutamiento alveolar. Bajo demanda se pueden sumbinistrar rangos de presión especiales (0-40 cmH2O). On demand special pressure ranges (0-40 cmH2O) can be supplied. 100% MADE IN SPAIN - EUROPE AND US PATENTED Adjustable pressure Different Connections Connexiones Varias Single Package Unidades Individuales Non Magnetic Stainless Steel Acero Inoxidable No Magnético Ergonomic Handwheel Pomo de ajuste ergonomico Cpap/Respirator/resuscitator system Funciona con Cpap y Respiradores y Resuciiadores Operating temperature: 5ºC to 40ºC Temperatura de trabajo: 5ºC hasta 40ºC www.redfluid.es | enricpalau@redfluid.es | 0034 937857566 | Carrer Foc 5, 08227 Terrassa (Barcel

EU Declaration of Conformity Manufacturers Name: SRN (Single Registration Number): Manufacturers Address: Name of the Device (s): CARRER FOC 5, 08227 TERRASSA (BARCELONA), SPAIN Product code: ADJUSTABLE 0-20 mmH2O PEEP VALVE MALE INLET REUSABLE PEEP18, PEEP22, PEEP30 I. Rule II. Annex VIII MDR 2017/745 Compliance with standards: Conformity assessment route: REDFLUID uses the following procedures for the CE-labeling of their products according the Regulation MDR 2017/745 and amended by Regulation EU 2020/561: Class I : EU Declaration of Conformity according to article 19 and annex IV This...

WE HEREBY CERTIFY THAT THE MANAGEMENT SYSTEM OPERATED BY CERTIFICAMOS QUE EL SISTEMA DE GESTIÓN DE REDFLUID, S.L. C/ FOC 5 - 08227 TERRASSA (BARCELONA) SPAIN OPERATIVE UNITS / INSTALACIÓN DE C/ FOC 5 - 08227 TERRASSA (BARCELONA) SPAIN IS IN COMPLIANCE WITH THE STANDARD / REÚNE LOS REQUISITOS DE LA NORMA ISO 13485:2016 FOR THE FOLLOWING ACTIVITIES / PARA LAS SIGUIENTES ACTIVIDADES Gestión de la fabricación, ensamblado, venta y distribución de válvulas manuales peeps Manufacturing management, assembly, sales and distribution of manual peep valves Further clarifications regarding the...

Health Canada Santé Canada Medical Devices Directorate Direction des instruments médicaux COVID-19 Medical Device Authorization for Importation or Sale Autorisation d’importation ou de mise en vente d’un instrument médical relatif au COVID-19 Authorization Reference Number : Numéro de référence de l’autorisation Issue Date: Device Class/Classe de l'instrument : 2 Pursuant to section 5 of the Interim Order Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19, made by the Minister of Health on March 18, 2020, the medical device listed below is now authorized...

Health Canada Santé Canada Medical Devices Directorate Direction des instruments médicaux Application Number: Numéro de la demande: Manufacturer ID: Identificateur du fabricant:

Health Canada Santé Canada Medical Devices Directorate Direction des instruments médicaux Components/Parts/Accessories/Devices for this Licence Les composantes, parties, accessoires et instruments médicaux pour cette homologation PEEP VALVE 0-20 CMH20 INLET Device ID/No de l'instrument: 1022009 Device Identifier / Identificateur de l'instrument (Model/Catalog Detail/No de modèle/Catalogue): PEEP.22 PEEP VALVE 0-40 CMH20 INLET Device ID/No de l'instrument: 1022010 Device Identifier / Identificateur de l'instrument (Model/Catalog Detail/No de modèle/Catalogue): REC.22 Application Number:...