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FDA 510(k)

Monoject™ 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）

K 號：K243652 · 2024-12-19

申請人Cardinalhealth
決定日期2024-12-19
產品代碼PNR
諮詢委員會GU
決定相當於

器材摘要

Monoject™ Enteral Syringe with ENFit Connector (401SE); Monoject™ Enteral Syringe with ENFit Connector (403SE); Monoject™ Enteral Syringe with ENFit Connector (406SE); Monoject™ Enteral Syringe with ENFit Connector (412SE); Monoject™ Enteral Syringe with ENFit Connector (435SE); Monoject™ Enteral Syringe with ENFit Connector (460SE) is the device name listed in this FDA 510(k) record. The listed applicant is Cardinalhealth. It received FDA 510(k) clearance on 2024-12-19 under 510(k) number K243652. The device is classified under product code PNR. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Monoject™ Enteral Syringe with ENFit Connector (401SE); Monoject™ Enteral Syringe with ENFit Connector (403SE); Monoject™ Enteral Syringe with ENFit Connector (406SE); Monoject™ Enteral Syringe with ENFit Connector (412SE); Monoject™ Enteral Syringe with ENFit Connector (435SE); Monoject™ Enteral Syringe with ENFit Connector (460SE)?

Monoject™ Enteral Syringe with ENFit Connector (401SE); Monoject™ Enteral Syringe with ENFit Connector (403SE); Monoject™ Enteral Syringe with ENFit Connector (406SE); Monoject™ Enteral Syringe with ENFit Connector (412SE); Monoject™ Enteral Syringe with ENFit Connector (435SE); Monoject™ Enteral Syringe with ENFit Connector (460SE) is a medical device that received FDA 510(k) clearance on 2024-12-19. The listed applicant is Cardinalhealth. The 510(k) number is K243652.

When did Monoject™ Enteral Syringe with ENFit Connector (401SE); Monoject™ Enteral Syringe with ENFit Connector (403SE); Monoject™ Enteral Syringe with ENFit Connector (406SE); Monoject™ Enteral Syringe with ENFit Connector (412SE); Monoject™ Enteral Syringe with ENFit Connector (435SE); Monoject™ Enteral Syringe with ENFit Connector (460SE) receive FDA 510(k) clearance?

Monoject™ Enteral Syringe with ENFit Connector (401SE); Monoject™ Enteral Syringe with ENFit Connector (403SE); Monoject™ Enteral Syringe with ENFit Connector (406SE); Monoject™ Enteral Syringe with ENFit Connector (412SE); Monoject™ Enteral Syringe with ENFit Connector (435SE); Monoject™ Enteral Syringe with ENFit Connector (460SE) received FDA 510(k) clearance on 2024-12-19, under 510(k) number K243652.

Who is the listed applicant for Monoject™ Enteral Syringe with ENFit Connector (401SE); Monoject™ Enteral Syringe with ENFit Connector (403SE); Monoject™ Enteral Syringe with ENFit Connector (406SE); Monoject™ Enteral Syringe with ENFit Connector (412SE); Monoject™ Enteral Syringe with ENFit Connector (435SE); Monoject™ Enteral Syringe with ENFit Connector (460SE)?

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 Monoject™ Enteral Syringe with ENFit Connector (401SE); Monoject™ Enteral Syringe with ENFit Connector (403SE); Monoject™ Enteral Syringe with ENFit Connector (406SE); Monoject™ Enteral Syringe with ENFit Connector (412SE); Monoject™ Enteral Syringe with ENFit Connector (435SE); Monoject™ Enteral Syringe with ENFit Connector (460SE)?

The FDA product code for Monoject™ Enteral Syringe with ENFit Connector (401SE); Monoject™ Enteral Syringe with ENFit Connector (403SE); Monoject™ Enteral Syringe with ENFit Connector (406SE); Monoject™ Enteral Syringe with ENFit Connector (412SE); Monoject™ Enteral Syringe with ENFit Connector (435SE); Monoject™ Enteral Syringe with ENFit Connector (460SE) is PNR.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

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)；MonojecK230569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)K213174塞勒姆雙腔胃管用ENFit連接硅胶胃管K202217肯德爾NPWT創傷管理設備

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相關器械（代碼：PNR）

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。

K252483腸內針筒（20ml, 60ml）Chirana T.Injecta,A.S.K253268Profoject 鼻胃/口內喂養注射器；Profoject 可重用鼻胃/口內喂養注射器（型號A，型號B）；Profoject ENFit 轉接器；Profoject 鼻胃喂養注射器蓋CMT Health PTE., Ltd.K251585Profoject™ 給藥注射器CMT Health PTE., Ltd.K231300Nutricair 內腸注射器配ENFitCair LglK222772口服/腸內針筒配ENFit連接器Anhui Tiankang Medical Technology Co., Ltd.K211661ENFit腸內針筒（NUTRIFIT）Pentaferte Italia S.R.L.

官方來源

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