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Dispositivos MédicosCancelado

SISTEMA DE AQUECIMENTO E RESFRIAMENTO

80143600109

Registro cancelado em 19/08/2024 segundo a ANVISA.

Informações Gerais

Nome do produto

SISTEMA DE AQUECIMENTO E RESFRIAMENTO

Número de registro

80143600109

Classe de risco

II

Processo

25351659758201756

Empresa Detentora

País de fabricação

ESTADOS UNIDOS DA AMÉRICA

Registro

Situação

Cancelado

Vencimento

Vencido há 2166 dias22/11/2020
Histórico de Situação

Nenhuma mudança de situação registrada.

Apresentações / Modelos(200)

  • BRZ-ADP-000-000

    Applicator Adapter

  • BRZ-ADP-000-000_R

    Applicator Adapter Refurbished (Aplicador adaptador recondicionado)

  • BRZ-AP1-091-000

    CoolSmooth

  • BRZ-AP1-091-001

    CoolSmooth PRO Applicator

  • BRZ-AP1-091-001_R

    CoolSmooth Pro Applicator Refurbished (Aplicador CoolSmooth Pro recondicionado)

  • BRZ-AP2-020-000

    CoolMini Applicator

  • BRZ-AP2-020-000_R

    CoolMini Vacuum Applicator Refurbished (Aplicador de vácuo CoolMini recondicionado)

  • BRZ-AP2-140-000

    CoolAdvantage Petite Applicator

  • BRZ-AP2-140-000_R

    CoolAdvantage Petite Vacuum Applicator Refurbished (Aplicador de vácuo CoolAdvantage Petite recondicionado)

  • BRZ-AP2-160-000

    CoolAdvantage Applicator

  • BRZ-AP2-160-000_R

    CoolAdvantage Vacuum Applicator Refurbished (Aplicador de vácuo CoolAdvantage recondicionado)

  • BRZ-AP2-180-000

    CoolAdvantage Plus Applicator

  • BRZ-AP2-180-000_R

    CoolAdvantage Plus Vacuum Applicator Refurbished (Aplicador de vácuo CoolAdvantage Plus recondicionado)

  • BRZ-APK-06X-001

    CoolCard Accessory Pack

  • BRZ-APK-140-001

    CoolAdvantage Petite Consumables Pack, 24 Cycle

  • BRZ-APK-160-001

    CoolAdvantage Accessory Kit, 24 Pack

  • BRZ-APK-180-016

    CoolAdvantage Plus Consumables Pack, 16 Cycle

  • BRZ-APK-181-016

    CoolAdvantage Plus Accessory Pack

  • BRZ-AS1-000-002

    Pouched Applicator Support

  • BRZ-CD1-06X-QCK

    Placa EZ (Zeltiq EZ Card ou CoolCard)

  • BRZ-CD1-160-QCK

    CoolAdvantage Card Quick Check

  • BRZ-CD2-

    06X-001

  • BRZ-CD2-

    091-008

  • BRZ-CD2-

    140-003

  • BRZ-CD2-

    09X-001

  • BRZ-CD2-140-008

    CoolAdvantage Petite Card

  • BRZ-CD2-160-001

    CoolAdvantage Card, CD , Indirect 1 Cycle

  • BRZ-CD2-160-003

    CoolAdvantage Card, CD2 , Indirect 3 Cycles

  • BRZ-CD2-160-008

    CoolAdvantage Card, CD2, Indirect 8 Cycles

  • BRZ-CD2-160-012

    CoolAdvantage Card, CD2, Indirect 12 Cycles

  • BRZ-CD2-160-024

    Cool, Advantage Card, CD2 , Indirect 24 Cycles

  • BRZ-CD4-

    09X-008

  • BRZ-CD4-

    06X-003

  • BRZ-CD4-140-008

    CoolAdvantage Petite Card

  • BRZ-CD4-160-001

    CoolAdvantage Card, CD4, Direct, 1 Cycle

  • BRZ-CD4-160-003

    CoolAdvantage Card, CD4, Direct, 3 Cycles

  • BRZ-CD4-160-008

    CoolAdvantage Card, CD4, direct 8 Cycles

  • BRZ-CD4-160-012

    CoolAdvantage Card, CD4, direct 12 Cycles

  • BRZ-CD4-160-024

    CoolAdvantage Card, CD4, Direct, 24 Cycles

  • BRZ-CG1-BAM-110

    ZELTIQ Breeze Base Module

  • BRZ-CG1-BAM-220

    ZELTIQ CoolSculpting Base Module

  • BRZ-CG1-CIM-100

    ZELTIQ Breeze Control Unit

  • BRZ-CG1-CUD-110

    ZELTIQ CoolSculpting Control Unit

  • BRZ-CG1-CUD-220

    ZELTIQ CoolSculpting Control Unit

  • BRZ-CG1-UCB-000

    ZELTIQ CoolSculpting Upper Module

  • BRZ-CG1-UCD-000

    ZELTIQ Breeze Upper Module

  • BRZ-CG1-UMB-000

    ZELTIQ CoolSculpting Upper Module

  • BRZ-CG1-UMD-000

    ZELTIQ Breeze Upper Module

  • BRZ-CN1-140-000

    CoolAdvantage Petite with CoolFit Petite Contour

  • BRZ-CN1-160-000

    Contour, CoolCore Advantage

  • BRZ-CN1-180-000

    Contour, Coolcore, CoolAdvantage Plus, CoolCurve Plus

  • BRZ-CN2-140-000

    Contour, CoolCurve Petite, CoolAdvantage Petite

  • BRZ-CN2-160-000

    Contour, CoolCurve + Advantage

  • BRZ-CN2-180-000

    Contour, CoolAdvantage Plus, CoolCore Plus

  • BRZ-CN3-140-000

    Curve+Contour CoolAdvantage Petite

  • BRZ-CN3-160-000

    Contour, CoolFit Advantage

  • BRZ-FB1-09X-024

    CoolSmooth Foam Borders

  • BRZ-FT-POS-001

    Foot positioning guide

  • BRZ-GL1-140-008

    CoolAdhseive Petite Pad8

  • BRZ-GL1-180-008

    CoolAdhesive Plus Pad, 8 Pack

  • BRZ-GL3-160-008

    CoolAdhesive Pad, 8 Pack

  • BRZ-GS1-000-024

    CoolGel, Syringe, CoolMini Single Treatment, 24 pack

  • BRZ-GT1-1X0-008

    CoolAdvantage Gel Trap - 8 Pack

  • BRZ-GT1-02X-024

    CoolMini Gel Trap - 24 Pack

  • BRZ-GT1-160-024

    CoolAdvantage Gel Trap - 24 Pack

  • BRZ-GT1-180-

    008 CoolAdvantage Family Gel Trap, 8 Pack

  • BRZ-HNG-180-004

    Contour hanger Cooladvantage Plus

  • BRZ-LN1-02X-024

    CoolMini Liner Qty 24

  • BRZ-LN1-09X-024

    CoolSmooth Liner

  • BRZ-LN1-140-008

    CoolAdvantage Petite Gasket

  • BRZ-LN1-140-024

    Gasket, 24-Pack, CoolAdvantage Petite

  • BRZ-LN1-160-008

    CoolAdvantage Gasket

  • BRZ-LN1-180-008

    CoolAdvantage Plus Gasket/

  • BRZ-LN1-180-016

    CoolAdvantage Plus Gasket, 16 Pack

  • BRZ-LN2-06X-016

    Zeltiq Liner™ (Revestimento) ou EZ Liner ou CoolLiner)

  • BRZ-LN2-140-

    024 Gasket, 24-Pack, CoolAdvantage Petite

  • BRZ-LN2-160-024

    Gasket, 24-Pack, CoolAdvantage

  • BRZ-LNZ-180-001

    CoolAdvantage Plus Reusable Gasket 1 Pack

  • BRZ-MK-PHB-001

    Photography backdrop

  • BRZ-PD1-08X-008

    Protetor de gel (EZ Pad ou CoolGel ou gelpad)

  • BRZ-PSW-000-008

    Pretreatment Skin Wipe

  • BRZ-PSW-000-024

    Zeltiq Pretreatment Skin Wipe- Qty 24

  • BRZ-RP1-09X-024

    CoolSmooth Card Pack-24

  • BRZ-RP1-140-024

    Reorder Pack, 24 Cycles, CD1

  • BRZ-RP1-160-024

    CoolAdvantage Card- Reorder Pack-24 Cycles

  • BRZ-RP1-180-016

    CoolAdvantage Plus Reorder Pack, 16 Cycle, CD1

  • BRZ-RP1-ARM-001

    CoolSculpting Applicator Cable Support Arm

  • BRZ-RP1-CHL-000

    Chiller fluid

  • BRZ-RP2-

    140-024 Reorder Pack, 24 Cycles, CD2,

  • BRZ-RP2-06X-024

    CoolCard-Pack-24 Cycle

  • BRZ-RP2-09X-024

    CoolSmooth Card-Pack-24 Cycle

  • BRZ-RP2-160-024

    CoolAdvantage Card-Reorder Pack - 24 Cycles

  • BRZ-RP2-180-016

    CoolAdvantage Plus Reorder Pack, 16 Cycle, CD2, Indirect

  • BRZ-RP2-ARM-001

    CoolMini Support Arm

  • BRZ-RP3-02X-024

    CoolMini Reorder Pack-24 Cycles-CD3

  • BRZ-RP3-09X-048

    CoolSmooth Card-Pack-48 Cycle

  • BRZ-RP3-091-048

    CoolSmooth PRO CardPack-48 Cycle

  • BRZ-RP3-180-

    016 CoolAdvantage Plus Reorder Pack, 16 Cycles, CD3

  • BRZ-RP3-181-016

    CoolAdvantage Plus Reorder Pack, 16 Cycles, CD3

  • BRZ-RP4-09X-008

    CoolSmooth Card Pack-8

  • BRZ-RP4-09X-024

    CoolSmooth Card-Pack-24 Cycle

  • BRZ-RP4-140-024

    CoolAdvantage Petite Reorder Pack, 24 Cycles CD4

  • BRZ-RP4-160-024

    CoolAdvantage Reorder Pack, RP4, 24 Cycles, CD4

  • BRZ-RP4-180-016

    CoolAdvantage Plus Reorder Pack, 16 Cycle, Direct

  • BRZ-RPZ-181-016

    CoolAdvantage Plus Reorder Pack RP2, 16 Cycles, CD2

  • BRZ-SP1-02X-001

    Support Pillow

  • BRZ-SS1-09X-012

    CoolSmooth Securement System

  • BRZ-SS1-09X-012

    Securement System Qty 12

  • BRZ-SS1-140-002

    Comfort Strap, CoolAdvantage Petite

  • BRZ-SS1-160-002

    Comfort Strap, CoolAdvantage

  • BRZ-SS1-180-002

    Comfort Strap, CoolAdvantage Plus

  • BRZ-SS2-09X-012

    Securement Straps Short

  • BRZ-SS2-09X-012

    CoolSmooth Securement Strap, Short, Qty 12

  • BRZ-SS3-09X-012

    Assembly Pouched Securement Straps, CoolSmooth

  • BRZ-SS4-09X-012

    Center Securement Plate, CoolSmooth PRO

  • BRZ-SS5-091-004

    CoolSmooth Pro- Securement System

  • BRZ-SS6-000-000

    Support Pillow

  • BRZ-SS7-02X-002

    CoolMini, Pillow Securement Straps

  • BRZRP4-181-016

    CoolAdvantage Plus Reorder Pack, RP4, 16 Cycle, CD4

  • SA16448

    Lower Module, COM1, Inspected & Configured -220V (Refurbished)

  • SA16790

    Upper Module, COM1, InDirect (Refurbished)

  • SA17742

    Hardware Kit

  • SA17745

    Activation Kit

  • SA17892

    Hardware Standard Door Assembly

  • 201319 Activation Kit

  • 201930 Planning Template Coolmini

  • 204087 Planning Template Coolfit

  • 204088 Planning Template Coolcore

  • 204089 Planning Template Coolcurve

  • 204090 Planning Template Cooladvantage

  • 207204 Planning Template Coolmax

  • 207205 Planning Template Coolcurve

  • 207592 Plastic device to the applicator Cooladvantage

  • Bordas de Espuma (Foam Borders)

  • BRZ-APK-02X-001

  • BRZ-APK-091-001

  • BRZ-CD1-02X-QCK

  • BRZ-CD1-091-QCK

  • BRZ-CD1-09X-QCK

  • BRZ-CD1-140-QCK

  • BRZ-CD1-180-QCK

  • BRZ-CD2-02X-001

  • BRZ-CD2-02X-003

  • BRZ-CD2-02X-008

  • BRZ-CD2-02X-024

  • BRZ-CD2-06X-003

  • BRZ-CD2-06X-012

  • BRZ-CD2-06X-024

  • BRZ-CD2-091-001

  • BRZ-CD2-091-003

  • BRZ-CD2-091-024

  • BRZ-CD2-09X-003

  • BRZ-CD2-09X-008

  • BRZ-CD2-09X-024

  • BRZ-CD2-140-001

  • BRZ-CD2-140-024

  • BRZ-CD2-180-001

  • BRZ-CD2-180-003

  • BRZ-CD2-180-008

  • BRZ-CD2-180-016

  • BRZ-CD4-02X-001

  • BRZ-CD4-02X-003

  • BRZ-CD4-02X-008

  • BRZ-CD4-02X-024

  • BRZ-CD4-06X-001

  • BRZ-CD4-06X-012

  • BRZ-CD4-06X-024

  • BRZ-CD4-091-001

  • BRZ-CD4-091-003

  • BRZ-CD4-091-008

  • BRZ-CD4-091-024

  • BRZ-CD4-09X-001

  • BRZ-CD4-09X-003

  • BRZ-CD4-09X-024

  • BRZ-CD4-140-001

  • BRZ-CD4-140-003

  • BRZ-CD4-140-024

  • BRZ-CD4-180-001

  • BRZ-CD4-180-008

  • BRZ-CD4-180-016

  • BRZ-RP1-02X-024

  • BRZ-RP1-091-024

  • BRZ-RP2-02X-024

  • BRZ-RP2-091-008

  • BRZ-RP2-091-024

  • BRZ-RP4-02X-024

  • BRZ-RP4-091-008

  • BRZ-RP4-091-024

  • BRZCD4-180-003

  • Cabo do Aplicador

  • Cartão Refrigerante (Coolant)

  • Conector do Aplicador

  • Gaxeta (Gasket) - (Aplicador CoolAdvantage)

  • Gel

  • Gel Trap (CoolAdvantage e CoolMini Aplicadores)

  • Lenço Umedecido para Pré Tratamento (Pretreatment Skin Wipe)

  • Pager

  • Protetor de Gel (Gel Pad)

  • Revestimento (Liner)

  • Sistema de Segurança (Securement System).

Instruções de Uso e Arquivos(1)

Manual Cool - BRZ-101-TUM-PTB-L COM1 UM for Brazil_201002.pdf

INSTRUÇÕES DE USO OU MANUAL DO USUÁRIO DO PRODUTO

T1951716318/04/2023, 14:25Exp. 0388726237

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

Documentos Técnicos(5)

342005520003/11/2020

EQUIPAMENTO – Retificação – Correção pela ANVISA

Anuído

239272520931/08/2020

EQUIPAMENTO – Retificação – Correção pela ANVISA

Publicado deferimento

027041923310/04/2023

EQUIPAMENTO – Alteração de notificação classe II – Implementação imediata

Publicado deferimento

138030622904/04/2022

EQUIPAMENTO – Alteração de notificação classe II – Implementação imediata

Não anuído

103537321925/03/2021

EQUIPAMENTO – Alteração de notificação classe II – Implementação imediata

Publicado deferimento

Produtos relacionados

Fonte: Dados Abertos ANVISA + API Oficial ANVISA
Última atualização: 12 de Outubro de 2026
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