FDA 510(k)

Nutricair腸內ENFit轉接器：ENFit公頭－階梯/耶誕樹型接頭

K 號：K231299 · 2024-01-22

決定日期2024-01-22

產品代碼PIO

諮詢委員會GU

決定相當於

器材摘要

Nutricair enteral ENFit adapter: ENFit male – stepped/Christmas tree connector is the device name listed in this FDA 510(k) record. The listed applicant is Cair Lgl. It received FDA 510(k) clearance on 2024-01-22 under 510(k) number K231299. The device is classified under product code PIO. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Nutricair enteral ENFit adapter: ENFit male – stepped/Christmas tree connector?

Nutricair enteral ENFit adapter: ENFit male – stepped/Christmas tree connector is a medical device that received FDA 510(k) clearance on 2024-01-22. The listed applicant is Cair Lgl. The 510(k) number is K231299.

When did Nutricair enteral ENFit adapter: ENFit male – stepped/Christmas tree connector receive FDA 510(k) clearance?

Nutricair enteral ENFit adapter: ENFit male – stepped/Christmas tree connector received FDA 510(k) clearance on 2024-01-22, under 510(k) number K231299.

Who is the listed applicant for Nutricair enteral ENFit adapter: ENFit male – stepped/Christmas tree connector?

The FDA 510(k) record lists Cair Lgl as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Nutricair enteral ENFit adapter: ENFit male – stepped/Christmas tree connector?

The FDA product code for Nutricair enteral ENFit adapter: ENFit male – stepped/Christmas tree connector is PIO.

其他以 Cair Lgl 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。

K231300Nutricair 內腸注射器配ENFit K213258鼻胃管 - ENFit 接口 - 聚氯乙烯 K210598兒童鼻胃管輸食管 - 单一ENFit端口 K171117Carefusion NeutraClear 非針連接器 (EL-NC1000)K171118Carefusion NeutraClear 多連接器擴展組合，配無針接頭(們)K171132Carefusion NeutraClear 非針連接器

查看所有 7 項裝置 →

相關器械（代碼：PIO）

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。

K233190ENFit 轉接器Jiangsu Caina Medical Co.,Ltd K220165腸內轉換接頭GBUK Group, Ltd.K162254西迪克腸內 ENFit 經過式連接器Cedic S.R.L.K151237Nutrisafe 2- ENFit 轉接器Vygon

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。