DECLARACIÓN DE CONFORMIDAD INICIAL PM CLASE I- II

Transcripción

1 AÑO DEL CENTENARIO DE LA REFORMA UNIVERSITARIA Ministerio de Salud Secretaría de Políticas, Regulación e Institutos A.N.M.A.T. ANEXO II DECLARACIÓN DE CONFORMIDAD INICIAL PM CLASE I- II Número de revisión: 00 Número de PM: Nombre Descriptivo del producto: Accesorios para circuitos respiratorios Código de identificación y nombre técnico UMDNS: Circuitos Respiratorios Externos Clase de Riesgo: Clase II Marca de (los) producto(s) médico(s): Flexicare Modelos (en caso de clase II y equipos): Adult Angled Viral / Bacterial Filter Adult Viral / Bacterial Filter Adult Viral / Bacterial Filter with Tethered Cap Port Adult Angled Viral / Bacterial Filter with Tethered Cap Port LS Luersafe Adult Viral / Bacterial Filter with Self-Sealing Port Adult Viral / Bacterial Filter with Tethered Cap Port + Low Profile Elbow Mini Viral / Bacterial Filter Mini Viral / Bacterial Filter with Tethered Cap Port LS Luersafe Mini Viral / Bacterial Filter with Self-Sealing Port Mini Viral / Bacterial Filter with Tethered Cap Port + Low Profile Elbow Adult Angle Viral / Bacterial Filter + HME Adult Viral / Bacterial Filter + HME Adult Viral / Bacterial Filter + HME with Tethered Cap Port LS Luersafe Adult Viral / Bacterial Filter + HME with Self-Sealing Port Adult Angled Viral / Bacterial Filter + HME with Tethered Cap Port PM Número: Página 1 de 9 Página 1 de 9

2 LS Luersafe Adult Angled Viral / Bacterial Filter + HME with Self-Sealing Port Adult Viral / Bacterial Filter + HME with Tethered Cap Port + Low Profile Elbow Adult Viral / Bacterial Filter with HME Tethered Cap Port + 15mm Tube + Low Profile Elbow Adult Viral / Bacterial Filter with Tethered Cap Port + Expandable Catheter Mount + Double Swivel Elbow + Elastomeric Cap Mini Viral / Bacterial Filter Mini Viral / Bacterial Filter with Tethered Cap Port LS Luersafe Mini Viral / Bacterial Filter with Self-Sealing Port Mini Viral / Bacterial Filter with Tethered Cap Port + Low Profile Elbow Mini Viral / Bacterial Filter with Tethered Cap Port + Expandable Catheter Mount + Double Swivel Elbow + Elastomeric Cap Adult Pleated Hydrophobic Bacterial / Viral Filter Adult Pleated Hydrophobic Bacterial / Viral Filter with Tethered Cap Port Adult Pleated Hydrophobic Bacterial / Viral Filter with Tethered Cap Port + Expandable Catheter Mount + Double Swivel Elbow + Elastomeric Cap Paediatric Pleated Hydrophobic Bacterial / Viral Filter Paediatric Pleated Hydrophobic Bacterial / Viral Filter with Tethered Cap Port Paediatric Pleated Hydrophobic Bacterial / Viral Filter with Tethered Cap Port + Catheter Mount + Plain Elbow Pulmonary Function Test Filter STR Sterile Mini Viral / Bacterial Filter with Tethered Cap Port STR Sterile Adult Viral / Bacterial Filter STR Sterile Adult Viral / Bacterial Filter with Tethered Cap Port STR Sterile Adult Angled Viral / Bacterial Filter STR Sterile Adult Angled Viral / Bacterial Filter with Tethered Cap Port STR Sterile Paediatric Pleated Hydrophobic Bacterial / Viral Filter with Tethered Cap Port STR Sterile Adult Pleated Hydrophobic Bacterial / Viral Filter STR Sterile Adult Pleated Hydrophobic Bacterial / Viral Filter with Tethered Cap Port STR Sterile Adult Pleated Hydrophobic Bacterial / Viral Filter with Tethered Cap Port + Expandable Catheter Mount + Double Swivel Elbow + Elastomeric Cap STR Sterile Mini Viral / Bacterial Filter + HME with Tethered Cap Port STR Sterile Adult Viral / Bacterial Filter + HME STR Sterile Adult Angled Viral / Bacterial Filter + HME STR Sterile Adult Angled Viral / Bacterial Filter + HME with Tethered Cap Port LSSTR Sterile Luersafe Adult Angled Viral / Bacterial Filter + HME with Self-Sealing Port LSSTR Sterile Luersafe Adult Viral / Bacterial Filter + HME with Self-Sealing Port STR Sterile Adult Viral / Bacterial Filter + HME with Tethered Cap Port STR Sterile Adult Viral / Bacterial Filter with HME Tethered Cap Port + 15mm Tube + Low Profile Elbow LS Luersafe Adult Angled Viral / Bacterial Filter with Self-Sealing Port Star Lumen Oxygen Tubing 100m Star Lumen Oxygen Tubing with connectors - 2.1m Star Lumen Oxygen Tubing with one narrow and one wide connector - 2.1m Oxygen Bubble Tubing (3mm) 30m coil in dispensing box Oxygen Bubble Tubing (3mm) 100m coil in dispensing box Oxygen Bubble Tubing 1.8m mm Corrugated Tubing with 45cm repeat, 50m coil in dispensing box PM Número: Página 2 de 9 Página 2 de 9

3 mm Corrugated Tubing with 15cm repeat, 50m coil in dispensing box mm Corrugated Tubing 2m with two 22mm female connectors Entonox Mouth Piece Catheter Mount Standard 15mm Tube, 22mm F and 15mm F Connectors /640 Catheter Mount Standard 15mm Tube with Detachable Low Profile Elbow, 22mm F and 15mm /641 Catheter Mount Standard 15mm Tube with Detachable Luer Lock Elbow, 22mm F and 15mm /645 Catheter Mount Standard 15mm Tube with Detachable Double Swivel Elbow, Elastomeric Cap, 22mm F and 15mm Catheter Mount Standard 15mm Tube with Low Profile Elbow, 22mm F and 15mm Catheter Mount Standard 15mm Tube with Luer Lock Elbow, 22mm F and 15mm Catheter Mount Standard 15mm Tube with Low Profile Elbow, Elastomeric Cap, 22mm F and 15mm F/22mm Catheter Mount Standard 15mm Tube with Double Swivel Elbow, 22mm F and 15mm Catheter Mount Standard 15mm Tube with Double Swivel Elbow, Elastomeric Cap, 22mm F and 15mm Catheter Mount Flexi-Lock Tube, 15mm M and 15mm F Connectors /640 Catheter Mount Flexi-Lock Tube with Detachable Low Profile Elbow, 22mm F and 15mm /643 Catheter Mount Flexi-Lock Tube with Detachable Double Swivel Elbow, 22mm F and 15mm F/15mm M Connectors /645 Catheter Mount Flexi-Lock Tube with Detachable Double Swivel Elbow, Elastomeric Cap, 22mm F and 15mm F/15mm M Connectors /643 Catheter Mount Flexi-Lock Tube with Detachable Double Swivel Elbow, 22mm F and 15mm F/15mm M Connectors /645 Catheter Mount Flexi-Lock Tube with Detachable Double Swivel Elbow, Elastomeric Cap, 22mm F and 15mm F/15mm M Connectors Catheter Mount Flexi-Lock Tube, 22mm F and 15mm F Connectors Catheter Mount Flexi-Lock Tube with Low Profile Elbow, 22mm F and 15mm F/22mm M Connectors Catheter Mount Flexi-Lock Tube with Luer Lock Elbow, 22mm F and 15mm F/22mm M Connectors Catheter Mount Flexi-Lock Tube with Elbow, Elastomeric Cap, 22mm F and 15mm Catheter Mount Flexi-Lock Tube with Double Swivel Elbow, 22mm F and 15mm Catheter Mount Flexi-Lock Tube with Double Swivel Elbow, Elastomeric Cap, 22mm F and 15mm Catheter Mount Smooth Bore, 22mm F and 15mm F Connectors Catheter Mount Smooth Bore with Low Profile Elbow, 22mm F and 15mm F/22mm M Connectors Catheter Mount Smooth Bore with Luer Lock Elbow, 22mm F and 15mm F/22mm M Connectors Catheter Mount Smooth Bore with Elbow, Elastomeric Cap, 22mm F and 15mm Catheter Mount Smooth Bore with Double Swivel Elbow, 22mm F and 15mm F/22mm PM Número: Página 3 de 9 Página 3 de 9

4 M Connectors Catheter Mount Smooth Bore with Double Swivel Elbow, Elastomeric Cap, 22mm F and 15mm Adult Self-Sealing Water Trap Paediatric - Self-Sealing Water Trap Neonatal - Self-Sealing Water Trap Oxygen Tubing T connector Oxygen Tubing Right Angled Connector Oxygen Tubing Straight Connector Oxygen Tubing Swivel Connector Oxygen Tubing Swivel Connector with Clip mm M / F Serrated Connector mm M / 22mm M / 15mm F Connector mm F / 15mm M Connector mm M / M Connector mm M / F Connector mm M / 30F Scavenging Connector mm M / F with Barbed Right Angled Connector mm M / F with Luer Right Angled Connector mm F / F with Luer Right Angled Connector F / F Connector with Port and Plug mm M / F Connector with Port and Plug M / M / M T-piece M / M / F T-piece mm M / M / M T-piece with port mm M / M / F T-piece with port mm M / 22mm M / 15mm F with Luer Right Angled Connector mm M / 22mm M / 15mm F with Barbed Right Angled Connector mm Plain Parallel Y-Piece mm Plain Parallel Y-Piece + Monitoring Ports mm Parallel Y-Piece with CO2 Luer Lock Port mm Swivel Y-Piece LS 22mm Swivel Y-Piece with LuerSafe Connector mm Plain Parallel Y-Piece mm Y-Piece with Monitoring Ports Elbow Low Profile 22M / 15F Elbow with Luer Lock Port 22M / 15F Elbow with Elastomeric Cap for Suction 22M / 15F Double Swivel Elbow 22M / 15F Double Swivel Elbow with Suction Cap 22M / 15F Monitoring Line with M / M Connectors 2m Tubing X Monitoring Line with M / M Connectors 3m Tubing Monitoring Line with F / F Connectors 2m Tubing Monitoring Line with M / F Connectors 2m Tubing Luersafe Monitoring Line with M / M Connectors 2m Tubing Luersafe Monitoring Line with M / F Connectors 2m Tubing NL 2 Litre Reservoir Bag with 22mm Female Connector NL 3 Litre Reservoir Bag with 22mm Female Connector NL 0.5 Litre Reservoir Bag with 15 mm Female Connector Open Tail PM Número: Página 4 de 9 Página 4 de 9

5 NL 1 Litre Reservoir Bag with 22mm Female Connector NL 0.5 Litre Reservoir Bag with 22mm Female Connector Closed Tail Bubble Humidifier with Fine Diffuser 400ml, 4 PSI (recommended for hospital) Bubble Humidifier with PVC Diffuser 300ml, 6 PSI (recommended for home use) mm Corrugated tube. 45cm repeat in dispensing box. 50m mm Blue Corrugated tube. 45cm repeat in dispensing box. Low Compliance mm Corrugated tube. 45cm repeat in dispensing box Corrugated Tube (1.6m) Breathing System with Exhaust Port Adult Angled Viral / Bacterial Filter + HME with Tethered Cap Port LS Luersafe Adult Angled Viral / Bacterial Filter + HME with Self-Sealing Port Nose Clip Composición cuali-cuanti porcentual exacta (si corresponde): No aplica Indicación/es autorizada/s: Los accesorios se emplean en circuitos respiratorios dedicados a la conducción de gases en pacientes adultos, niños y lactantes. Período de vida útil (si corresponde): 5 años Método de Esterilización (si corresponde): No aplica Forma de presentación: Por unidad Condición de venta: Venta Exclusiva a Profesionales e Instituciones Sanitarias Nombre del fabricante: Flexicare Medical Limited Lugar/es de elaboración: Cynon Valley Business Park, Mountain Ash, CF454ER. Reino Unido. En nombre y representación de la firma Electromedik S.A., el responsable legal y el responsable técnico declaran bajo juramento que los productos médicos enumerados en el presente Anexo, satisfacen los Requisitos Esenciales de Seguridad y Eficacia (R.E.S.E.) previstos por la Disposición ANMAT N 4306/99, que cumplen y se encuentra a disposición de la Autoridad Sanitaria la documentación técnica que contenga los requerimientos solicitados en los Anexos III.B y III.C del Reglamento Técnico aprobado por Disposición ANMAT N 2318/02 (TO 2004) y PM Número: Página 5 de 9 Página 5 de 9

6 Disposición ANMAT Nº 727/13. CUMPLIMIENTO DE R.E.S.E. DISPOSICIÓN ANMAT N 4306/99 Y GESTIÓN DE RIESGO ENSAYO/VALIDACION/GESTION DE RIESGO 1. BS EN ISO 14971:2012 EN ISO 13845:2012 ISO : BS EN ISO 14971:2012 ISO 9001: BS EN ISO 14971:2012 ISO 9001:2008 EN 868-5: ISO :2009 BS EN ISO 14971:2012 ISO 9001: BS EN ISO 14971:2012 EN 868-5: BS EN ISO 14971:2012 MDD 93/42/EEC BS EN ISO 14971:2012 ISO : /7.3 BS EN ISO 14971:2012 ISO : N/A 7.5 BS EN ISO 14971:2012 LABORATORI O/N DE PROTOCOLO No aplica FECH A DE EMISI ÓN no aplica PM Número: Página 6 de 9 Página 6 de 9

7 ISO :2009 BS EN 15986: NA 8.1 BS EN ISO 14971:2012 ISO 9001: NA 8.3 BS EN ISO 14971:2012 ISO 11135: EN ISO 14971:2012 ISO 11135: ISO 11135: BS EN 556-1: BS EN ISO 14971: BS EN ISO 14971: BS EN ISO 14971: /11/12.1/12.2/12.3/12.4/12.5/12.6 NA BS EN ISO 14971: / NA BS EN ISO 14971: /12.8/12.9 NA 13.1: PM Número: Página 7 de 9 Página 7 de 9

8 a,b 13.3 c,d,e,f BS EN 556-1:2001 EN ISO : g,h,i,l,n NA 13.3 j,k 13.3 m ISO :2014 BS EN ISO ISO 13485: a, d, g, h, k 13.6 b,e,f,i,j,l,m,n,o,p,q NA 13.6 c BS EN ISO 14971:2012 El responsable legal y su responsable técnico son responsables de la veracidad de la documentación e información presentada y declaran bajo juramento mantener en su establecimiento y a disposición de la autoridad sanitaria la documentación allí declarada y la que establece la Disposición 727/13, bajo apercibimiento de lo que establece la Ley N , el Decreto N 341/92 y las que correspondan del Código Penal en caso de falsedad. En caso de inexactitud o falsedad de la información o documentación, la Administración Nacional podrá suspender, cancelar, prohibir la comercialización y solicitar retiro del mercado de lo ya autorizado e iniciar los sumarios que pudieran corresponder. LUGAR Y FECHA: Argentina, 19 marzo 2018 Responsable Legal Firma y Sello Responsable Técnico Firma y Sello Ministerio de Salud PM Número: Página 8 de 9 Página 8 de 9

9 Secretaría de Políticas, Regulación e Institutos A.N.M.A.T. La presente DECLARACIÓN DE CONFORMIDAD ha sido emitida de acuerdo con las previsiones de la Disposición ANMAT Nº 727/13 y N 5706/17, quedando inscripta en el Registro Nacional de Productores y Productos de Tecnología Médica (R.P.P.T.M.) a favor de Electromedik S.A. bajo el número PM Se autoriza la comercialización del/los producto/s identificados en la presente declaración de conformidad en la Ciudad de Buenos Aires a los días 19 marzo 2018 la cual tendrá una vigencia de cinco (5) años a contar de la fecha. Dirección de Evaluación de Registro Firma y Sello Dirección Nacional de Productos Médicos Firma y Sello Tramitada por Expediente N : PM Número: Página 9 de 9 Página 9 de 9