皖宣械备20180001号

安徽京泠医疗器械有限公司

安徽省宣城市经济技术开发区龟灵路18号

安徽省宣城市经济技术开发区龟灵路18号

氧气面罩

HX.O01/S、M、L、XL；HX.O01T 5mm/1.8m；HX.O01T 5mm/2m；HX.O01T 5mm/2.13m；HX.O01T 5mm/2.5m；HX.O01T 5mm/3m；HX.O01T 5mm/5m；HX.O01T 5mm/10m；HX.O01T 6mm/1.8m；HX.O01T 6mm/2m；HX.O01T 6mm/2.13m；HX.O01T 6mm/2.5m；HX.O01T 6mm/3m；HX.O01T 6mm/5m；HX.O01T 6mm/10m；HX.O01 XL/A；HX.O01 L/A；HX.O01 MA；HX.O01 S/A；HX.O01 XL/N；HX.O01 L/N；HX.O01 M/N；HX.O01 S/N；HX.O02/S、M、L、XL；HX.O03/S、M、L、XL；HX.O04/S、M、L、XL；HX.O05/L；HX.O11/XS、S、M、L、XL、XXL；HX.O12/XS、S、M、L、XL、XXL；HX.O12 V

产品主要采用无毒高分子材料制造，面罩若以消毒方式提供，消毒后每只面罩的细菌菌落总数≦20cfu/g，并不得检出霉菌和致病菌。若采用环氧乙烷消毒，每只面罩的环氧乙烷残留量应不大于1.5mg。

与呼吸设备和/或供氧(气)装置连接，作为氧气的输送通道，放置或固定于患者面部、颈部，用于呼吸治疗。

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宣城市食品药品监督管理局

2018-01-08

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