FDA 510(k)

Nutricair Enteral Syringe with ENFit

K号: K231300 · 2023-10-06

决定日期2023-10-06

产品代码PNR

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决定实质等同

器械摘要

Nutricair Enteral Syringe with ENFit is the device name listed in this FDA 510(k) record. The listed applicant is Cair Lgl. It received FDA 510(k) clearance on 2023-10-06 under 510(k) number K231300. The device is classified under product code PNR. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Nutricair Enteral Syringe with ENFit?

Nutricair Enteral Syringe with ENFit is a medical device that received FDA 510(k) clearance on 2023-10-06. The listed applicant is Cair Lgl. The 510(k) number is K231300.

When did Nutricair Enteral Syringe with ENFit receive FDA 510(k) clearance?

Nutricair Enteral Syringe with ENFit received FDA 510(k) clearance on 2023-10-06, under 510(k) number K231300.

Who is the listed applicant for Nutricair Enteral Syringe with ENFit?

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 Syringe with ENFit?

The FDA product code for Nutricair Enteral Syringe with ENFit is PNR.

列明Cair Lgl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。

K231299Nutricair enteral ENFit adapter: ENFit male – stepped/Christmas tree connector K213258鼻胃管 - ENFit 端口 - 聚氯乙烯 K210598儿童鼻胃管 - 单个ENFit端口 K171117Carefusion NeutraClear 无针连接器 (EL-NC1000)K171118Carefusion NeutraClear 多功能扩展套件，带无针连接器 K171132Carefusion NeutraClear 无针连接器

查看所有 7 个设备 →

相关器械（代码：PNR）

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。

K252483肠内注射器（20ml，60ml）Chirana T.Injecta,A.S.K253268Profoject 鼻饲/口饲注射器；Profoject 可重复使用鼻饲/口饲注射器（型号A，型号B）；Profoject ENFit 连接器；Profoject 鼻饲注射器盖CMT Health PTE., Ltd.K251585Profoject™ 鼻饲注射器CMT Health PTE., Ltd.K243652Monoject® 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)Cardinalhealth K222772带ENFit连接器的口腔/肠内注射器Anhui Tiankang Medical Technology Co., Ltd.K211661ENFit 肠内注射器 (NUTRIFIT)Pentaferte Italia S.R.L.

官方来源

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