SISTEMA DE AQUECIMENTO E RESFRIAMENTO
Registro cancelado em 19/08/2024 segundo a ANVISA.
Nome do produto
SISTEMA DE AQUECIMENTO E RESFRIAMENTO
Número de registro
80143600109
Nome técnico
Classe de risco
II
Processo
25351659758201756
Razão social
Fabricante
País de fabricação
ESTADOS UNIDOS DA AMÉRICA
Apresentações / Modelos(200)
BRZ-ADP-000-000Applicator Adapter
BRZ-ADP-000-000_RApplicator Adapter Refurbished (Aplicador adaptador recondicionado)
BRZ-AP1-091-000CoolSmooth
BRZ-AP1-091-001CoolSmooth PRO Applicator
BRZ-AP1-091-001_RCoolSmooth Pro Applicator Refurbished (Aplicador CoolSmooth Pro recondicionado)
BRZ-AP2-020-000CoolMini Applicator
BRZ-AP2-020-000_RCoolMini Vacuum Applicator Refurbished (Aplicador de vácuo CoolMini recondicionado)
BRZ-AP2-140-000CoolAdvantage Petite Applicator
BRZ-AP2-140-000_RCoolAdvantage Petite Vacuum Applicator Refurbished (Aplicador de vácuo CoolAdvantage Petite recondicionado)
BRZ-AP2-160-000CoolAdvantage Applicator
BRZ-AP2-160-000_RCoolAdvantage Vacuum Applicator Refurbished (Aplicador de vácuo CoolAdvantage recondicionado)
BRZ-AP2-180-000CoolAdvantage Plus Applicator
BRZ-AP2-180-000_RCoolAdvantage Plus Vacuum Applicator Refurbished (Aplicador de vácuo CoolAdvantage Plus recondicionado)
BRZ-APK-06X-001CoolCard Accessory Pack
BRZ-APK-140-001CoolAdvantage Petite Consumables Pack, 24 Cycle
BRZ-APK-160-001CoolAdvantage Accessory Kit, 24 Pack
BRZ-APK-180-016CoolAdvantage Plus Consumables Pack, 16 Cycle
BRZ-APK-181-016CoolAdvantage Plus Accessory Pack
BRZ-AS1-000-002Pouched Applicator Support
BRZ-CD1-06X-QCKPlaca EZ (Zeltiq EZ Card ou CoolCard)
BRZ-CD1-160-QCKCoolAdvantage Card Quick Check
BRZ-CD2-06X-001
BRZ-CD2-091-008
BRZ-CD2-140-003
BRZ-CD2-09X-001
BRZ-CD2-140-008CoolAdvantage Petite Card
BRZ-CD2-160-001CoolAdvantage Card, CD , Indirect 1 Cycle
BRZ-CD2-160-003CoolAdvantage Card, CD2 , Indirect 3 Cycles
BRZ-CD2-160-008CoolAdvantage Card, CD2, Indirect 8 Cycles
BRZ-CD2-160-012CoolAdvantage Card, CD2, Indirect 12 Cycles
BRZ-CD2-160-024Cool, Advantage Card, CD2 , Indirect 24 Cycles
BRZ-CD4-09X-008
BRZ-CD4-06X-003
BRZ-CD4-140-008CoolAdvantage Petite Card
BRZ-CD4-160-001CoolAdvantage Card, CD4, Direct, 1 Cycle
BRZ-CD4-160-003CoolAdvantage Card, CD4, Direct, 3 Cycles
BRZ-CD4-160-008CoolAdvantage Card, CD4, direct 8 Cycles
BRZ-CD4-160-012CoolAdvantage Card, CD4, direct 12 Cycles
BRZ-CD4-160-024CoolAdvantage Card, CD4, Direct, 24 Cycles
BRZ-CG1-BAM-110ZELTIQ Breeze Base Module
BRZ-CG1-BAM-220ZELTIQ CoolSculpting Base Module
BRZ-CG1-CIM-100ZELTIQ Breeze Control Unit
BRZ-CG1-CUD-110ZELTIQ CoolSculpting Control Unit
BRZ-CG1-CUD-220ZELTIQ CoolSculpting Control Unit
BRZ-CG1-UCB-000ZELTIQ CoolSculpting Upper Module
BRZ-CG1-UCD-000ZELTIQ Breeze Upper Module
BRZ-CG1-UMB-000ZELTIQ CoolSculpting Upper Module
BRZ-CG1-UMD-000ZELTIQ Breeze Upper Module
BRZ-CN1-140-000CoolAdvantage Petite with CoolFit Petite Contour
BRZ-CN1-160-000Contour, CoolCore Advantage
BRZ-CN1-180-000Contour, Coolcore, CoolAdvantage Plus, CoolCurve Plus
BRZ-CN2-140-000Contour, CoolCurve Petite, CoolAdvantage Petite
BRZ-CN2-160-000Contour, CoolCurve + Advantage
BRZ-CN2-180-000Contour, CoolAdvantage Plus, CoolCore Plus
BRZ-CN3-140-000Curve+Contour CoolAdvantage Petite
BRZ-CN3-160-000Contour, CoolFit Advantage
BRZ-FB1-09X-024CoolSmooth Foam Borders
BRZ-FT-POS-001Foot positioning guide
BRZ-GL1-140-008CoolAdhseive Petite Pad8
BRZ-GL1-180-008CoolAdhesive Plus Pad, 8 Pack
BRZ-GL3-160-008CoolAdhesive Pad, 8 Pack
BRZ-GS1-000-024CoolGel, Syringe, CoolMini Single Treatment, 24 pack
BRZ-GT1-1X0-008CoolAdvantage Gel Trap - 8 Pack
BRZ-GT1-02X-024CoolMini Gel Trap - 24 Pack
BRZ-GT1-160-024CoolAdvantage Gel Trap - 24 Pack
BRZ-GT1-180-008 CoolAdvantage Family Gel Trap, 8 Pack
BRZ-HNG-180-004Contour hanger Cooladvantage Plus
BRZ-LN1-02X-024CoolMini Liner Qty 24
BRZ-LN1-09X-024CoolSmooth Liner
BRZ-LN1-140-008CoolAdvantage Petite Gasket
BRZ-LN1-140-024Gasket, 24-Pack, CoolAdvantage Petite
BRZ-LN1-160-008CoolAdvantage Gasket
BRZ-LN1-180-008CoolAdvantage Plus Gasket/
BRZ-LN1-180-016CoolAdvantage Plus Gasket, 16 Pack
BRZ-LN2-06X-016Zeltiq Liner™ (Revestimento) ou EZ Liner ou CoolLiner)
BRZ-LN2-140-024 Gasket, 24-Pack, CoolAdvantage Petite
BRZ-LN2-160-024Gasket, 24-Pack, CoolAdvantage
BRZ-LNZ-180-001CoolAdvantage Plus Reusable Gasket 1 Pack
BRZ-MK-PHB-001Photography backdrop
BRZ-PD1-08X-008Protetor de gel (EZ Pad ou CoolGel ou gelpad)
BRZ-PSW-000-008Pretreatment Skin Wipe
BRZ-PSW-000-024Zeltiq Pretreatment Skin Wipe- Qty 24
BRZ-RP1-09X-024CoolSmooth Card Pack-24
BRZ-RP1-140-024Reorder Pack, 24 Cycles, CD1
BRZ-RP1-160-024CoolAdvantage Card- Reorder Pack-24 Cycles
BRZ-RP1-180-016CoolAdvantage Plus Reorder Pack, 16 Cycle, CD1
BRZ-RP1-ARM-001CoolSculpting Applicator Cable Support Arm
BRZ-RP1-CHL-000Chiller fluid
BRZ-RP2-140-024 Reorder Pack, 24 Cycles, CD2,
BRZ-RP2-06X-024CoolCard-Pack-24 Cycle
BRZ-RP2-09X-024CoolSmooth Card-Pack-24 Cycle
BRZ-RP2-160-024CoolAdvantage Card-Reorder Pack - 24 Cycles
BRZ-RP2-180-016CoolAdvantage Plus Reorder Pack, 16 Cycle, CD2, Indirect
BRZ-RP2-ARM-001CoolMini Support Arm
BRZ-RP3-02X-024CoolMini Reorder Pack-24 Cycles-CD3
BRZ-RP3-09X-048CoolSmooth Card-Pack-48 Cycle
BRZ-RP3-091-048CoolSmooth PRO CardPack-48 Cycle
BRZ-RP3-180-016 CoolAdvantage Plus Reorder Pack, 16 Cycles, CD3
BRZ-RP3-181-016CoolAdvantage Plus Reorder Pack, 16 Cycles, CD3
BRZ-RP4-09X-008CoolSmooth Card Pack-8
BRZ-RP4-09X-024CoolSmooth Card-Pack-24 Cycle
BRZ-RP4-140-024CoolAdvantage Petite Reorder Pack, 24 Cycles CD4
BRZ-RP4-160-024CoolAdvantage Reorder Pack, RP4, 24 Cycles, CD4
BRZ-RP4-180-016CoolAdvantage Plus Reorder Pack, 16 Cycle, Direct
BRZ-RPZ-181-016CoolAdvantage Plus Reorder Pack RP2, 16 Cycles, CD2
BRZ-SP1-02X-001Support Pillow
BRZ-SS1-09X-012CoolSmooth Securement System
BRZ-SS1-09X-012Securement System Qty 12
BRZ-SS1-140-002Comfort Strap, CoolAdvantage Petite
BRZ-SS1-160-002Comfort Strap, CoolAdvantage
BRZ-SS1-180-002Comfort Strap, CoolAdvantage Plus
BRZ-SS2-09X-012Securement Straps Short
BRZ-SS2-09X-012CoolSmooth Securement Strap, Short, Qty 12
BRZ-SS3-09X-012Assembly Pouched Securement Straps, CoolSmooth
BRZ-SS4-09X-012Center Securement Plate, CoolSmooth PRO
BRZ-SS5-091-004CoolSmooth Pro- Securement System
BRZ-SS6-000-000Support Pillow
BRZ-SS7-02X-002CoolMini, Pillow Securement Straps
BRZRP4-181-016CoolAdvantage Plus Reorder Pack, RP4, 16 Cycle, CD4
SA16448Lower Module, COM1, Inspected & Configured -220V (Refurbished)
SA16790Upper Module, COM1, InDirect (Refurbished)
SA17742Hardware Kit
SA17745Activation Kit
SA17892Hardware 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)
| Código | Tipo | Arquivo | Expedição | Expediente |
|---|---|---|---|---|
| T19517163 | INSTRUÇÕES DE USO OU MANUAL DO USUÁRIO DO PRODUTO | Manual Cool - BRZ-101-TUM-PTB-L COM1 UM for Brazil_201002.pdf | 18/04/2023, 14:25 | 0388726237 |
INSTRUÇÕES DE USO OU MANUAL DO USUÁRIO DO PRODUTO
A atualização destes documentos é executada pela empresa responsável pela regularização do produto.
Documentos Técnicos(5)
| Petição / Protocolo | Data | Assunto | Situação |
|---|---|---|---|
| 3420055200 | 03/11/2020 | EQUIPAMENTO – Retificação – Correção pela ANVISA | Anuído |
| 2392725209 | 31/08/2020 | EQUIPAMENTO – Retificação – Correção pela ANVISA | Publicado deferimento |
| 0270419233 | 10/04/2023 | EQUIPAMENTO – Alteração de notificação classe II – Implementação imediata | Publicado deferimento |
| 1380306229 | 04/04/2022 | EQUIPAMENTO – Alteração de notificação classe II – Implementação imediata | Não anuído |
| 1035373219 | 25/03/2021 | EQUIPAMENTO – Alteração de notificação classe II – Implementação imediata | Publicado deferimento |
EQUIPAMENTO – Retificação – Correção pela ANVISA
Anuído
EQUIPAMENTO – Retificação – Correção pela ANVISA
Publicado deferimento
EQUIPAMENTO – Alteração de notificação classe II – Implementação imediata
Publicado deferimento
EQUIPAMENTO – Alteração de notificação classe II – Implementação imediata
Não anuído
EQUIPAMENTO – Alteração de notificação classe II – Implementação imediata
Publicado deferimento
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