FDA 510(k)

BD PureHub 消毒帽

K 號：K193190 · 2020-11-09

決定日期2020-11-09

產品代碼QBP

諮詢委員會醫療設備規範文本翻譯如下： HO 注意：原文中未提供具體的醫療設備規範文本，因此上述翻譯僅為示例。請提供完整的規範文本以便進行準確翻譯。

決定相當於

器材摘要

BD PureHub Disinfecting Cap is the device name listed in this FDA 510(k) record. The listed applicant is Becton, Dickinson and Company. It received FDA 510(k) clearance on 2020-11-09 under 510(k) number K193190. The device is classified under product code QBP. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the BD PureHub Disinfecting Cap?

BD PureHub Disinfecting Cap is a medical device that received FDA 510(k) clearance on 2020-11-09. The listed applicant is Becton, Dickinson and Company. The 510(k) number is K193190.

When did BD PureHub Disinfecting Cap receive FDA 510(k) clearance?

BD PureHub Disinfecting Cap received FDA 510(k) clearance on 2020-11-09, under 510(k) number K193190.

Who is the listed applicant for BD PureHub Disinfecting Cap?

The FDA 510(k) record lists Becton, Dickinson and Company as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BD PureHub Disinfecting Cap?

The FDA product code for BD PureHub Disinfecting Cap is QBP.

其他以 Becton, Dickinson and Company 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K262163BD BBL穆勒-金頓II培養基（陽離子調整）；BD Difco穆勒-金頓培養基 K260128BD Preset™ 和 BD A-Line™ 动脈血液採集針筒 K252378BD® MiniDraw™ 微量血採集系統配BD® MiniDraw™ SST™ 微量血採集管 K252506BD Vacutainer® 安全鎖™ 採血套組; BD Vacutainer® 安全鎖™ 採血套組配預裝持桿器 K260184Onclarity™ 自取樣套件 K252040BD Vacutainer® 血漿分離管 (PST™), BD Vacutainer® 钠鹽肝素採血管

查看所有 102 項裝置 →

相關器械（代碼：QBP）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K252006OTTO™ 消毒帽Icu Medical, Inc.K251592SteriHub™ 過濾消毒設備及保護蓋1World Vista Medical K223914ACTIV™ 帽Cleansite Medical, Inc.K200299Curos噴射消毒帽3M Company K192382CapKlenZStar Mountain Medical, Inc.K190918SwabTip 男性消毒帽Icu Medical

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。