FDA 510(k)

塞勒姆雙腔胃管用ENFit連接硅胶胃管

K 號：K213174 · 2022-05-19

決定日期2022-05-19

產品代碼PIF

諮詢委員會GU

決定相當於

器材摘要

Salem Sump Silicone Dual Lumen Stomach Tube with ENFit Connection is the device name listed in this FDA 510(k) record. The listed applicant is Cardinalhealth. It received FDA 510(k) clearance on 2022-05-19 under 510(k) number K213174. The device is classified under product code PIF. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Salem Sump Silicone Dual Lumen Stomach Tube with ENFit Connection?

Salem Sump Silicone Dual Lumen Stomach Tube with ENFit Connection is a medical device that received FDA 510(k) clearance on 2022-05-19. The listed applicant is Cardinalhealth. The 510(k) number is K213174.

When did Salem Sump Silicone Dual Lumen Stomach Tube with ENFit Connection receive FDA 510(k) clearance?

Salem Sump Silicone Dual Lumen Stomach Tube with ENFit Connection received FDA 510(k) clearance on 2022-05-19, under 510(k) number K213174.

Who is the listed applicant for Salem Sump Silicone Dual Lumen Stomach Tube with ENFit Connection?

FDA 510(k) 記錄將 Cardinalhealth 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Salem Sump Silicone Dual Lumen Stomach Tube with ENFit Connection?

The FDA product code for Salem Sump Silicone Dual Lumen Stomach Tube with ENFit Connection is PIF.

其他以 Cardinalhealth 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。

K261749卡迪那爾健康公司尼龍藍色檢查手套，已經通過與化學療法藥物和芬太尼鹽酸鹽的測試。K252313卡迪那爾健康公司硅膠檢查手套長袖 K243660Monoject™ 1mL結核菌素針筒 Luer-Lock尖端 (1180100777)；Monoject™ 3mL針筒，Luer-Lock尖端 (1180300777)；Monoject™ 6mL針筒，Luer-Lock尖端 (1180600777)；Monoject™ 12mL針筒，Luer-Lock尖端 (1181200777)；Monoject™ 20mL針筒，Luer-Lock尖端 (1182000777)；Monoject™ 35mL針筒，Luer-Lock尖端 (1183500777)；Monoject™ 60mL針筒，Luer-Lock尖端 (1186000777)；Monoject™ 3mL針筒，Luer-Lock尖端 (8881513934)；Monoject™ 6mL針筒，Luer-Lock尖端 (8881516937)；Monojec K243652Monoject™ 飲食針筒配ENFit連接器（401SE）；Monoject™ 飲食針筒配ENFit連接器（403SE）；Monoject™ 飲食針筒配ENFit連接器（406SE）；Monoject™ 飲食針筒配ENFit連接器（412SE）；Monoject™ 飲食針筒配ENFit連接器（435SE）；Monoject™ 飲食針筒配ENFit連接器（460SE）K230569卡迪那爾健康外科口罩防霧水凝膠 (3級)；卡迪那爾健康外科口罩防霧水凝膠 (1級)K202217肯德爾NPWT創傷管理設備

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相關器械（代碼：PIF）

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。

K260110danumed 食道造口按鈕擴充組Danumed Medizintechnik GmbH K253715Edi 尿管 ENFit 6Fr/48 cm (6893166)；Edi 尿管 ENFit 6Fr/49cm (6893273)；Edi 尿管 ENFit 6Fr/50cm (6893274)；Edi 尿管 ENFit 8Fr/50cm (6893275)；Edi 尿管 ENFit 8Fr/100cm (6893276)；Edi 尿管 ENFit 8Fr/125cm (6893277)；Edi 尿管 ENFit 12Fr/125cm (6893278)；Edi 尿管 ENFit 16Fr/125cm (6893279)Maquet Critical Care AB K254170經皮內視鏡胃造口術（PEG）套件Degania Silicone , Ltd.K242917腸內引流系統，腸內藥劑吸管HMC Premedical S.p.A.K250481延伸喂食設備搭配ENFit™連接器SKY Medical, a.s.K240052一次性腸內營養輸注套組Beijing L&Z Medical Technology Development Co., Ltd.

官方來源

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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。