230207
III
current
Ventilators, Intensive Care呼吸机,重症监护
This profile provides complete Hong Kong MDACS registration information for Ventilators, Intensive Care. Review device classification, authorised representative (AR) details, manufacturer contacts, product codes, and regulatory milestones. Pure Global AI delivers bilingual transparency for medical device registrations across Asia.
Product Info: Ventilators, Intensive Care
產品資訊： 呼吸机,重症监护
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
III
Product Code
17429
Product Code Detail
17429 Ventilators, Intensive Care
State
current
Status
N/A
Brand
Puritan Bennett 980 Ventilator System and Accessories
清教徒贝内特 980 呼吸机系统和配件
Manufacturer (製造商)
Covidien LLC
Covidien Llc
United States
美国
15 Hampshire Street
Mansfield MA 02048
USA
汉普郡街 15 号
马萨诸塞州曼斯菲尔德 02048
美国
Authorised Representative (AR)
Regulatory Timeline
Registration Date
June 26, 2023
Expiry Date
June 26, 2028
Product Models
Puritan Bennett 980 Universal Ventilator (980A1ENNISB), Puritan Bennett 980 Universal Ventilator DC Compressor Configuration (980A3ENNISB), Capnography Sensor, Reusable (10087409), End Tidal CO2 Monitoring Option (10084332), Proximal Flow Monitoring Option (10084331), Ped/Adult Expiratory Filter, Disposable (10043551), Ped/Adult CO2 Adapter, Disposable (10078387), Proximal Flow Sensors (10047078), Adult Expiratory Filter, Reusable (10063033), Pediatric and Adult CO2 Airway Adapter, Reusable (10083942), Neonatal and Pediatric CO2 Airway Adapter, Reusable (10083943), Neonatal and Pediatric CO2 Adapter, Disposable (10078386), Exhalation Valve Flow Sensor Reprocessing Kit (10086048), Rechargeable Lithium Ion Battery (10086042), Neonatal Expiratory Bracket & Filter (10095100)
清教徒贝内特 980 通用呼吸机 (980A1ENNISB), 清教徒贝内特 980 通用呼吸机直流压缩机配置 (980A3ENNISB), 二氧化碳监测传感器, 可重复使用 (10087409), 潮气末 CO2 监测选件 (10084332), 近端流量监测选件 (10084331), ped/成人呼气过滤器, 一次性 (10043551), ped/成人 CO2 适配器, 一次性 (10078387), 近端流量传感器 (10047078), 成人呼气过滤器, 可重复使用 (10063033), 儿科和成人 CO2 气道适配器, 可重复使用(10083942),新生儿和儿科CO2气道适配器,可重复使用(10083943),新生儿和儿科CO2适配器,一次性(10078386),呼气阀流量传感器再处理套件(10086048),可充电锂离子电池(10086042),新生儿呼气支架和过滤器(10095100)