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Dispositivos MédicosAtivo

RESMED MASKS V

80047300628
Informações Gerais

Nome do produto

RESMED MASKS V

Número de registro

80047300628

Nome técnico

Mascaras

Classe de risco

II

Processo

25351411068201606

Empresa Detentora

Razão social

MEDSTAR IMPORTAÇÃO E EXPORTAÇÃO LTDA

CNPJ

03.580.620/0001-35

Fabricante

RESMED PTY LTD.

País de fabricação

AUSTRÁLIA

Registro

Situação

Ativo

Vencimento

Registro vigente

Registro de prazo indeterminado

Histórico de Situação
VálidoATIVO07/05/2026

Detectado a cada sincronização diária com a ANVISA.

Apresentações / Modelos(307)

  • 16015 Chin Restraint

  • 16118 HEADGEAR SMALL

  • 16119 HEADGEAR, LARGE

  • 16333 Mirage Micro Mask SML-AMER

  • 16334 Mirage Micro Mask MED&LG-AMER

  • 16335 Mirage Micro Mask LG-WD&XL-AME

  • 16358 Mirage Micro Mask SML-Internet Pk

  • 16359 Mirage Micro Mask MED&LG-Internet Pkg

  • 16360 Mirage Micro Mask LG-WD&XL-Internet Pkg

  • 16375 Mirage Micro SLM SML

  • 16376 Mirage Micro SLM MED&LG

  • 16377 Mirage Micro SLM LG-WD&XL

  • 16378 Mirage Micro Frame Sys SML-US

  • 16379 Mirage Micro Frame Sys MED-US

  • 16380 Mirage Micro Frame Sys LG-US

  • 16381 Mirage Micro Frame Sys LG-WD-U

  • 16382 Mirage Micro Frame Sys XL-US

  • 16383 Mirage Micro Frame Assy SML-US

  • 16384 Mirage Micro Frame Asy STD-US

  • 16385 Mirage Micro Frm Sys MED&LG-US

  • 16386 Mirage Micro Frm Sys LG-WD&XL-US

  • 16387 MIRAGE MICRO DIFFUSED ELBOW

  • 16388 Mirage Micro Cushion SML

  • 16389 Mirage Micro Cushion MED

  • 16390 Mirage Micro Cushion LG

  • 16391 Mirage Micro Cushion LG-WD

  • 16392 Mirage Micro Cushion XL

  • 16394 Mirage Micro Mask Frame

  • 16395 Mirage Micro Mask Frame-SML

  • 16399 MIRAGE MICRO DIFFUSED ELBOW

  • 38804 HumidX

  • 38805 HumidX Plus

  • 38824 AirFit P10 for AirMini Mask Pack

  • 38845 P10 Connector for AirMini

  • 38852 P10 AirMini Frame SYS – XS

  • 38853 P10 AirMini Frame SYS – S

  • 38854 P10 AirMini Frame SYS – M

  • 38855 P10 AirMini Frame SYS – L

  • 60013 VISTA/KIDSTA CUSHION SML

  • 61010 MIRAGE KIDSTA SML USA

  • 61011 MIRAGE KIDSTA SML ENG

  • 61012 Mirage Kidsta Small French

  • 61013 Mirage Micro for Kids SML-AMER

  • 61014 Mirage Micro for Kids SLM-SML

  • 61020 VISTA/KIDSTA HEADGEAR SML

  • 61025 Headgear Mirage Kidsta Clip-2pk

  • 61026 Headgear Clip Mirage Kidsta -10pk

  • 61108 Mask Promo Pack Latin America

  • 61600 Mirage SoftGel Mask SML-AMER

  • 61601 Mirage SoftGel Mask MED-AMER

  • 61602 Mirage SoftGel Mask LG-AMER

  • 61603 Mirage SoftGel Mask LW-AMER

  • 61621 Mirage SoftGel Mask SLM-SML

  • 61622 Mirage SoftGel Mask SLM-MED

  • 61623 Mirage SoftGel Mask SLM-LG

  • 61624 Mirage SoftGel Mask SLM-LW

  • 61625 Mirage SoftGel Promo Pack-S

  • 61626 Mirage SoftGel Frame Sys SML

  • 61627 Mirage SoftGel Frame Sys-MED

  • 61628 Mirage SoftGel Frame Sys LG

  • 61629 Mirage SoftGel Frame Sys LW

  • 61630 Mirage SoftGel Promo Pack-M

  • 61631 Mirage SoftGel Cushion SML

  • 61632 Mirage SoftGel Cushion-MED

  • 61633 Mirage SoftGel Cushion LG

  • 61634 Mirage SoftGel Cushion LW

  • 61635 Mirage SoftGel Promo Pack-M

  • 61640 Mirage SoftGel Promo Pack-LW

  • 61646 Mirage SoftGel Mask SML-TPM

  • 61647 Mirage SoftGel Mask LW-TPM

  • 61648 Mirage SoftGel SML-AMER SAMPLE

  • 61649 Mirage SoftGel MED-AMER SAMPLE

  • 61650 Mirage SoftGel LG-AMER SAMPLE

  • 61651 Mirage SoftGel LW-AMER SAMPLE

  • 61700 Quattro FX FFM SML-AMER

  • 61701 Quattro FX FFM MED-AMER

  • 61702 Quattro FX FFM LGE-AMER

  • 61715 Quattro FX FFM SML-SLM

  • 61716 Quattro FX FFM MED-SLM

  • 61717 Quattro FX FFM LGE-SLM

  • 61718 Quattro Fx Mask SML-Internet Package

  • 61719 Quattro Fx Mask MED-Internet Package

  • 61720 Quattro Fx Mask LGE-Internet Package

  • 61721 Quattro FX FFM Cushion-SML

  • 61722 Quattro FX FFM Cushion – MED

  • 61723 Quattro FX FFM Cushion-LGE

  • 61724 Quattro FX FFM Frame System-SM

  • 61725 Quattro FX FFM Frame System-ME

  • 61726 Quattro FX FFM Frame System-LG

  • 61727 Quattro FX FFM Frame Assy-SML

  • 61728 Quattro FX FFM Frame Assy-MED

  • 61729 Quattro FX FFM Frame Assy-LGE

  • 61730 Quattro FX FFM Frame-SML

  • 61731 Quattro FX FFM Frame-MED

  • 61732 Quattro FX FFM Frame-LGE

  • 61733 Quattro FX FFM Headgear-Medium

  • 61734 Quattro FX FFM Headgear-Small

  • 61735 Quattro FX MASK SML-AMER SAMPL

  • 61736 Quattro FX MASK MED-AMER SAMPL

  • 61737 Quattro FX MASK LGE-AMER SAMPL

  • 61738 Quattro FX FFM Headgear-Lge

  • 61758 Quattro FX FFM Soft Sleeves

  • 61759 Quattro FX FFM Spring Frame-SM

  • 61760 Quattro FX FFM Spring Frame-ME

  • 61761 Quattro FX FFM Spring Frame-LG

  • 61762 NV Quattro FX FFM-Elbow

  • 62501 Quattro FX For Her SML-AMER

  • 62502 Quattro FX For Her MED-AMER

  • 62504 Quattro FX For Her SML-SLM

  • 62505 Quattro FX For Her MED-SLM

  • 62506 Quattro FX For Her FFM Hgear-S

  • 62507 Quattro FX For Her FFM Hgear-S

  • 62508 Quattro FX For Her SML Sample

  • 62509 Quattro FX For Her MED Sample

  • 62510 QFX For Her Spring Frame-SML

  • 62511 QFX For Her Spring Frame-MED

  • 62513 QFX For Her FFM Frame Sys-SML

  • 62514 QFX For Her FFM Frame Sys-MED

  • 62515 Quattro FX Grey Headgear Clip

  • 62516 Quattro FX For Her Soft Sleeves

  • 62701 Quattro Air FFM SML

  • 62702 Quattro Air FFM MED

  • 62703 Quattro Air FFM LGE

  • 62728 Quattro Air FFM XSML-SLM

  • 62729 Quattro Air FFM SML-SLM

  • 62730 Quattro Air FFM MED-SLM

  • 62731 Quattro Air FFM LGE-SLM

  • 62732 Quattro Air FFM XSML-Trade Sample

  • 62733 Quattro Air FFM SML-Trade Sample

  • 62734 Quattro Air FFM MED-Trade Sample

  • 62735 Quattro Air FFM LGE-Trade Sample

  • 62736 AIRFIT F10 FOR HER CUSHION XS

  • 62736 Quattro Air FFM XSML-Cushion Spare

  • 62737 AIRFIT F10 CUSHION S

  • 62737 Quattro Air FFM SML-Cushion Spare

  • 62738 AIRFIT F10 CUSHION M

  • 62738 Quattro Air FFM MED-Cushion Spare

  • 62739 AIRFIT F10 CUSHION L

  • 62739 Quattro Air FFM LGE-Cushion Spare

  • 62740 Quattro Air FFM for Her XSML-AMER

  • 62741 Quattro Air FFM for Her SML-AMER

  • 62742 Quattro Air FFM for Her MED-AMER

  • 62752 Quattro Air Frame System XSML

  • 62753 Quattro Air Frame System SML

  • 62754 Quattro Air Frame System MED

  • 62755 Quattro Air Frame System LRG

  • 62756 Quattro Air Mask Headgear

  • 62757 Quattro Air Mask Headgear SML

  • 62758 Quattro Air For Her Headgear SML

  • 62759 Quattro Air For Her Headgear

  • 62760 Quattro Air Mask Frame

  • 62762 Quattro Air Mask Elbow

  • 62778 QUATTRO AIR NV XS

  • 62779 QUATTRO AIR NV S

  • 62780 QUATTRO AIR NV M

  • 62781 QUATTRO AIR NV L

  • 62798 QUATTRO AIR NV FRAME SYSTEM XS

  • 62799 QUATTRO AIR NV FRAME SYSTEM S

  • 62800 QUATTRO AIR NV FRAME SYSTEM M

  • 62801 QUATTRO AIR NV FRAME SYSTEM L

  • 62823 QUATTRO AIR NV CUSHION XS

  • 62824 QUATTRO AIR NV CUSHION S

  • 62825 QUATTRO AIR NV CUSHION M

  • 62826 QUATTRO AIR NV CUSHION L

  • 62827 QUATTRO AIR NV ELBOW

  • 62848 QUATTRO AIR NV QUICK RELEASE

  • 62900 AirFit P10 Mask SYSTEM – AMER

  • 62910 AirFit P10 for Her SYS – AMER

  • 62920 AirFit P10 Frame SYS X-SMALL

  • 62921 AirFit P10 Frame SYS SMALL

  • 62922 AirFit P10 Frame SYS MEDIUM

  • 62923 AirFit P10 Frame SYS LARGE

  • 62925 AirFit P10 Mask SYSTEM – SLM

  • 62926 AirFit P10 Mask SYS - TRD Sample

  • 62927 AirFit P10 for Her SYS – SLM

  • 62928 AirFit P10 for Her SYS – SPL

  • 62930 AirFit P10 Pillow X-SMALL

  • 62931 AirFit P10 Pillow SMALL

  • 62932 AirFit P10 Pillow MEDIUM

  • 62933 AirFit P10 Pillow LARGE

  • 62935 AirFit P10 Headgear Assy

  • 62936 AirFit P10 for Her Headgear Assy

  • 62938 AirFit P10 Frame (1pk)

  • 62962 AirFit P10 Headgear clip(s) (1pk)

  • 62965 AirFit P10 Headgear clip(s) (25pk)

  • 63101 AIRFIT F10 FFM SML-AMER

  • 63102 AIRFIT F10 FFM MED-AMER

  • 63103 AIRFIT F10 FFM LGE-AMER

  • 63129 AIRFIT F10 FFM SML-SLM

  • 63130 AIRFIT F10 FFM MED-SLM

  • 63131 AIRFIT F10 FFM LGE-SLM

  • 63132 AIRFIT F10 FFM XSML-TRADE SAMPLE

  • 63133 AIRFIT F10 FFM SML-TRADE SAMPLE

  • 63134 AIRFIT F10 FFM MED-TRADE SAMPLE

  • 63135 AIRFIT F10 FFM LGE-TRADE SAMPLE

  • 63136 AirFit F10 FOR HER XS-TRADE

  • 63137 AIRFIT F10 MASK FRAME XS/S

  • 63138 AIRFIT F10 MASK FRAME M/L

  • 63139 AIRFIT F10 FOR HER XSML-AMER

  • 63140 AIRFIT F10 FOR HER SML-AMER

  • 63141 AIRFIT F10 FOR HER MED-AMER

  • 63160 AIRFIT F10 FRAME SYSTEM XSML

  • 63161 AIRFIT F10 FRAME SYSTEM SML

  • 63162 AIRFIT F10 FRAME SYSTEM MED

  • 63163 AIRFIT F10 FRAME SYSTEM LGE

  • 63164 AIRFIT F10 MASK HEADGEAR STD

  • 63165 AIRFIT F10 MASK HEADGEAR SML

  • 63166 AIRFIT F10 MASK HEADGEAR LGE

  • 63167 AIRFIT F10 FOR HER HEADGEAR

  • 63168 AIRFIT F10 FOR HER HEADGEAR STD

  • 63169 AIRFIT F10 FOR HER FFM XSML-SLM

  • 63170 AIRFIT F10 FOR HER FFM SML-SLM

  • 63171 AIRFIT F10 FOR HER FFM MED-SLM

  • 63172 AirFit F10 FOR HER SML-TRADE

  • 63173 AirFit F10 FOR HER MD-TRADE

  • 63182 AIRFIT F10 SOFT SLEEVES

  • 63200 AIRFIT N10 STD

  • 63201 AIRFIT N10 FOR HER SML

  • 63202 AIRFIT N10 Wide

  • 63203 AirFit N10 Std Sys – Sample

  • 63204 AirFit N10 for Her Sys – Sample

  • 63205 AirFit N10 Wide Sys – Sample

  • 63206 AirFit N10 Std Sys – SLM

  • 63207 AirFit N10 for Her Sys – SLM

  • 63208 AirFit N10 Wide Sys – SLM

  • 63228 AirFit N10 Sml Sys – SLM

  • 63229 AirFit N10 Sml Sys

  • 63230 AIRFIT 10 FRAME SYSTEM STD

  • 63231 AIRFIT N10 FRAME SYSTEM SML

  • 63232 AIRFIT N10 FRAME SYSTEM Wide

  • 63240 AIRFIT N10 CUSHION STD

  • 63241 AIRFIT N10 CUSHION SML

  • 63242 AIRFIT N10 CUSHION Wide

  • 63260 AIRFIT N10 MASK HEADGEAR STD

  • 63261 AIRFIT N10 MASK HEADGEAR SML

  • 63262 AIRFIT N10 HEADGEAR SML (blue)

  • 63270 AIRFIT N10 FRAME STD

  • 63280 AIRFIT N10 HEADGEAR CLIP

  • 63282 AirFit N10 SOFT SLEEVE

  • 63289 AirFit N10 Sml Sys – SLM AMER

  • 63400 AirFit F20 SML – AMER

  • 63401 AirFit F20 MED – AMER

  • 63402 AirFit F20 GE – AMER

  • 63403 AirFit F20 for Her SML – AMER

  • 63404 AirFit F20 for Her MED – AMER

  • 63445 AirFit F20 SML Sys – SLM

  • 63446 AirFit F20 MED Sys – SLM

  • 63447 AirFit F20 LGE Sys – SLM

  • 63448 AirFit F20 for Her SML – SLM

  • 63449 AirFit F20 for Her MED – SLM

  • 63450 AirFit F20 Starter Pack

  • 63451 AirFit F20 SML Sys – MULTI

  • 63452 AirFit F20 MED Sys – MULTI

  • 63453 AirFit F20 LGE Sys – MULTI

  • 63454 AirFit F20 for Her SML – MULTI

  • 63455 AirFit F20 for Her MED – MULTI

  • 63456 AirFit F20 For Her Starter Pack

  • 63460 AirFit F20 Frame Sys SML

  • 63461 AirFit F20 Frame Sys MED

  • 63462 AirFit F20 Frame Sys LGE

  • 63463 AirFit F20 for Her Frame Sys SML

  • 63464 AirFit F20 for Her Frame Sys MED

  • 63465 AirFit F20 Frame

  • 63466 AirFit F20 for Her Frame

  • 63467 AirFit F20 Cushion SML

  • 63468 AirFit F20 Cushion MED

  • 63469 AirFit F20 Cushion LGE

  • 63470 AirFit F20 Headgear SML

  • 63471 AirFit F20 Headgear STD

  • 63472 AirFit F20 Headgear LGE

  • 63473 AirFit F20 for Her Headgear STD

  • 63475 AirFit F20 Headgear Clip

  • 63476 AirFit F20 Elbow

  • 63477 AirFit F20 Soft sleeves

  • 63494 F30 QuietAir Elbow

  • 64100 AirFit F30 SML Sys – AMER

  • 64101 AirFit F30 MED Sys – AMER

  • 64104 AirFit F30 SML Sys – SLM

  • 64105 AirFit F30 MED Sys – SLM

  • 64140 AirFit F30 Starter Pack

  • 64141 AirFit F30 MULTI - SML

  • 64142 AirFit F30 MULTI - MED

  • 64150 AirFit F30 Cushion SML

  • 64151 AirFit F30 Cushion MED

  • 64155 AirFit F30 Frame SYS - SML

  • 64155 AirFit F30 Frame Sys SML

  • 64156 AirFit F30 Frame SYS - MED

  • 64156 AirFit F30 Frame Sys MED

  • 64159 AirFit F30 Frame

  • 64160 AirFit F30 Headgear - SML

  • 64161 AirFit F30 Headgear - STD

  • 64162 AirFit F30 Headgear - LGE

  • 64210 AirFit N30 Frame System SMALL

  • 64211 AirFit N30 Frame System MEDIUM

  • 64212 AirFit N30 Frame System SMALL WIDE

  • 64213 AirFit N30 Cushion SMALL

  • 64214 AirFit N30 Cushion MEDIUM

  • 64215 AirFit N30 Cushion SMALL WIDE

  • 64216 AirFit N30 Headgear

  • 64219 AirFit N30 Frame

  • 64221 AirFit N30 Frame MultiHole SLM

  • 64222 AirFit N30 Mask System SMALL

  • 64223 AirFit N30 Mask System MEDIUM

  • 64224 AirFit N30 Mask System SMALL WIDE

  • 64230 AirFit N30 SLM Mask System SMALL

  • 64231 AirFit N30 SLM Mask System MEDIUM

  • 64232 AirFit N30 SLM Mask System SMALL WIDE

Instruções de Uso e Arquivos(8)

IFU 638234.pdf AirFit F30 User Guide AMER Multi.PDF

INSTRUÇÕES DE USO OU MANUAL DO USUÁRIO DO PRODUTO

T2616501108/10/2024, 17:33Exp. 1383178241
IFU 628153.pdf AirFit N10 AirFit N10 for Her User Guide AMER Multi.PDF

INSTRUÇÕES DE USO OU MANUAL DO USUÁRIO DO PRODUTO

T2616500808/10/2024, 17:33Exp. 1383178241
IFU 628161.pdf AirFit F10 Air Fit F10 for Her User Guide AMER Multi.PDF

INSTRUÇÕES DE USO OU MANUAL DO USUÁRIO DO PRODUTO

T2616500908/10/2024, 17:33Exp. 1383178241
IFU 638220.pdf AirFit F20 AirTouch (QuietAir) F20 User Guide AMER Multi.PDF

INSTRUÇÕES DE USO OU MANUAL DO USUÁRIO DO PRODUTO

T2616501008/10/2024, 17:33Exp. 1383178241
IFU 638220.pdf AirFit F20 AirTouch (QuietAir) F20 User Guide AMER Multi.PDF

INSTRUÇÕES DE USO OU MANUAL DO USUÁRIO DO PRODUTO

T3782778625/05/2026, 17:14Exp. 0510436269
IFU 638234.pdf AirFit F30 User Guide AMER Multi.PDF

INSTRUÇÕES DE USO OU MANUAL DO USUÁRIO DO PRODUTO

T3782779225/05/2026, 17:14Exp. 0510436269
IFU 628153.pdf AirFit N10 AirFit N10 for Her User Guide AMER Multi.PDF

INSTRUÇÕES DE USO OU MANUAL DO USUÁRIO DO PRODUTO

T3782778325/05/2026, 17:14Exp. 0510436269
IFU 628161.pdf AirFit F10 Air Fit F10 for Her User Guide AMER Multi.PDF

INSTRUÇÕES DE USO OU MANUAL DO USUÁRIO DO PRODUTO

T3782778425/05/2026, 17:14Exp. 0510436269

A atualização destes documentos é executada pela empresa responsável pela regularização do produto.

Documentos Técnicos(3)

308710320408/10/2020

MATERIAL – Alteração de notificação – Implementação imediata

Publicado deferimento

308742420617/09/2020

MATERIAL – Alteração de cadastro – Implementação imediata – Alteração/inclusão/exclusão de fabricante legal ou unidade fabril, alteração apenas do nome comercial e/ou denominação nome/código do modelo comercial, componente de sistema, parte ou acessório, exclusão de modelos, exclusão de acessórios, alteração das condições de armazenamento e transporte, alteração do prazo de validade, alteração/inclusão de método de esterilização, alteração do modo de uso e das condições de manipulação

Publicado deferimento

456574922122/08/2022

MATERIAL - Retificação – Correção pela ANVISA

Publicado deferimento

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Fonte: Dados Abertos ANVISA + API Oficial ANVISA
Última atualização: 12 de Outubro de 2026
Ver na fonte oficial da ANVISA

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