FDA 510(k)

Vial2Bag Advanced® 13mm 混合装置

K号: K230988 · 2023-12-01

决定日期2023-12-01

产品代码LHI

咨询委员会医疗设备监管文本翻译如下： HO 请注意，由于您没有提供具体的医疗设备监管文本内容，以上仅为示例。请提供具体的文本内容以便进行准确的翻译。

决定实质等同

器械摘要

Vial2Bag Advanced® 13mm Admixture Device is the device name listed in this FDA 510(k) record. The listed applicant is West Pharma. Services IL, Ltd.. It received FDA 510(k) clearance on 2023-12-01 under 510(k) number K230988. The device is classified under product code LHI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Vial2Bag Advanced® 13mm Admixture Device?

Vial2Bag Advanced® 13mm Admixture Device is a medical device that received FDA 510(k) clearance on 2023-12-01. The listed applicant is West Pharma. Services IL, Ltd.. The 510(k) number is K230988.

When did Vial2Bag Advanced® 13mm Admixture Device receive FDA 510(k) clearance?

Vial2Bag Advanced® 13mm Admixture Device received FDA 510(k) clearance on 2023-12-01, under 510(k) number K230988.

Who is the listed applicant for Vial2Bag Advanced® 13mm Admixture Device?

The FDA 510(k) record lists West Pharma. Services IL, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Vial2Bag Advanced® 13mm Admixture Device?

The FDA product code for Vial2Bag Advanced® 13mm Admixture Device is LHI.

列明West Pharma. Services IL, Ltd.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

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相关器械（代码：LHI）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K252987ADRx® 混合设备Epic Medical Pte. , Ltd.K260301药瓶适配器Hangzhou Qiantang Longyue Biotechnology Co., Ltd.K250345Medline 袋式过滤器Medline Industries, LP K251715FlowArt® 安瓿瓶接入通风装置Asset Medikal K251676Medline Microtek C-Flo 瓶式过滤器，无菌（2000S）；Medline Microtek 瓶式过滤器 II，无菌（2002S）；Medline Microtek 瓶式过滤器，无菌（2006S）；Medline Microtek 转移装置，无菌（2008S）Microtek Medical, LLC K243404HyHub™ 和 HyHub™ Duo 瓶盖访问设备Takeda Pharmaceuticals

官方来源

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