acessórios cortex
Registro cancelado em 28/03/2022 segundo a ANVISA.
Nome do produto
acessórios cortex
Número de registro
10307270013
Nome técnico
Classe de risco
I
Processo
25351459825202111
Razão social
Fabricante
País de fabricação
ALEMANHA
Apresentações / Modelos(75)
0,68m Typ C
000-40-010 - USB cable
000-45-016 - O2 Sensor OOM109-C for MetaMax 3B/3X
000-45-020 - O2 Sensor, vacuum-sealed for MetaLyzer 3B/MetaLyzer II
000-45-037 - Smart HR sensor set H10
010-00-001 - Pediatric/Adult face mask adaptor for Cortex flow sensor
010-00-005 - Calibration gas bottle, 1 litre
010-00-012 - Pediatric head cap assembly, small
010-00-019 - Pediatric face mask, small
010-00-020 - Pediatric face mask, large
010-00-021 - Pediatric head cap assembly, large
010-00-026 - Nose clip (reusable) metal torsion spring design
010-00-050 - Face mask large dark-blue
010-00-051 - Face mask medium dark blue
010-00-052 - Face mask small dark blue
010-00-053 - Face mask extra small
010-00-054 - Face mask petite
010-00-055 - Head cap assembly for face mask extra small + petite
010-00-056 - Head cap assembly for face mask small + medium
010-00-057 - Head cap assembly for face mask large
010-00-059 - Medium face mask brace set
010-00-061 - Small face mask brace set
010-00-062 - Easy Release Clips
010-00-063 - Easy Release Clips black for dark blue mask set with red head cap assembly
010-00-064 - Large face mask brace set
010-00-065 - Extra small face mask brace set
010-00-066 - Petite face mask brace set
010-00-083 - Calibration syringe 3 litres
010-00-101 - Pediatric/Adult face mask adaptor for Cortex flow sensor with disposable turbine
010-00-103 - Adapter for volume flow sensor for spirometry handle
010-00-104 - Autoclavable mask adapter
010-00-105 - Mask adapter for bacteria & virus filter (BVF)
010-00-106 - BVF-adapter for disposable turbine
010-00-107 - BVF-adapter for reusable turbine
010-01-550 - Cortex disposable
010-01-791 - Calibration kit professional without carrying case
010-01-792 - Calibration kit professional with carrying case without gas
010-01-793 - Calibration kit professional
010-01-897 - Tube adaptor Gas-on-demand for non-CORTEX gas bottles
010-01-898 - Gas-on-demand-valve with adaptor for CORTEX gas bottle
010-15-103 - O-ring (green) for CORTEX volume flow sensor electronic with disposable turbine
010-15-104 - O-ring (black) for mask adaptor for CORTEX volume flow sensor with disposable turbine
010-70-001 - Carrying case calibration kit
1,40 m
130-00-013 - Back carrying system for Metamax 3B
130-01-015 - Sample line for MetaMax 3B 60cm
130-01-022 - Extension cable for volume flow sensor 1,40 m
130-01-032 - Volume flow sensor complete 0,6 m
130-01-033 - Electronic assembly with cable and temperature sensor 0,6m
130-01-090 - Connection cable, serial PC
131-01-051 - Connection cable PC USB – Telemetry
136-00-002 - Earphone with cable MetaMax
136-00-011 - MaxSport Jacket small with integrated battery pouch
136-00-012 - MaxSport Jacket large with integrated battery pouch
136-01-002 - Volume flow sensor, complete
136-01-007 - Electronic assembly with cable and temperature sensor 0,6m
136-01-015 - Sample line for MetaMax 3B
136-01-020 - Cortex volume flow sensor with disposable turbine Metamax 3B
136-01-021 - Cortex electronic for volume flow sensor with disposable turbine Metamax
136-01-026 - Sample line for Sample Flow Dryer MetaMax 3B
136-01-061 - GPS Receiver (Metamax 3B)
136-01-081 - Sample Flow Dryer MetaMax 3B
136-60-010 - Extension cable for volume flow sensor, stationary
136-70-013 - Carrying case MetaMax
200-01-017 - Volume flow sensor with temperature sensor for Metalyzer 3B, Metalyzer II
200-01-018 - Electronic assembly with temperature sensor for Metalyzer 3B, Metalyzer II
200-01-020 - Cortex Volume flow sensor with disposable turbine 200-01-090 - Connection cable, serial PC
200-01-160 - Sample line for MetaLyzer 3B
220-02-003 - Sample line for MetaLyzer 3B
220-70-001 - Carrying case Metalyzer 3B
23
236-01-011 - Volume flow sensor with temperature sensor for Metalyzer 3B, 2m
236-01-013 - Electronic assembly with temperature sensor 2m
dark blue
dark blue
Documentos Técnicos(2)
| Petição / Protocolo | Data | Assunto | Situação |
|---|---|---|---|
| 3928675214Primária | 04/11/2021 | MATERIAL – Notificação de Dispositivo Médico Classe I | Publicado deferimento |
| 0168942228 | 10/02/2022 | MATERIAL – Alteração de notificação – Implementação imediata | Publicado deferimento |
MATERIAL – Notificação de Dispositivo Médico Classe I
Publicado deferimento
Petição primáriaMATERIAL – Alteração de notificação – Implementação imediata
Publicado deferimento
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