Salem Sump 硅胶双腔胃管带 ENFit 连接
K号: K213174 · 2022-05-19
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决定日期2022-05-19
产品代码PIF
咨询委员会GU
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决定实质等同
器械摘要
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.
常见问题
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)记录显示Cardinalhealth为申请人。这本身并不能确立该设备的制造商。
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.
相关临床试验
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。
列明Cardinalhealth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。
K261749Cardinal Health 硝基蓝检查手套，经测试可用于化疗药物和芬太尼盐酸盐使用K252313Cardinal Health 氮化橡胶检查手套，延长袖口K243660Monoject® 1mL 结核菌素注射器 Luer-Lock 尖端 (1180100777); Monoject® 3mL 注射器，Luer-Lock 尖端 (1180300777); Monoject® 6mL 注射器，Luer-Lock 尖端 (1180600777); Monoject® 12mL 注射器，Luer-Lock 尖端 (1181200777); Monoject® 20mL 注射器，Luer-Lock 尖端 (1182000777); Monoject® 35mL 注射器，Luer-Lock 尖端 (1183500777); Monoject® 60mL 注射器，Luer-Lock 尖端 (1186000777); Monoject® 3mL 注射器，Luer-Lock 尖端 (8881513934); Monoject® 6mL 注射器 , Luer-Lock 尖端 (8881516937); MonojecK243652Monoject® 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)K230569Cardinal Health防雾水凝胶手术口罩（3级）；Cardinal Health防雾水凝胶手术口罩（1级）K202217Kendall NPWT 切口管理设备
相关器械（代码：PIF）
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。
K260110丹诺美德胃造口按钮延长套件Danumed Medizintechnik GmbHK253715Edi 导管 ENFit 6Fr/48 cm (6893166)；Edi 导管 ENFit 6Fr/49cm (6893273)；Edi 导管 ENFit 6Fr/50cm (6893274)；Edi 导管 ENFit 8Fr/50cm (6893275)；Edi 导管 ENFit 8Fr/100cm (6893276)；Edi 导管 ENFit 8Fr/125cm (6893277)；Edi 导管 ENFit 12Fr/125cm (6893278)；Edi 导管 ENFit 16Fr/125cm (6893279)Maquet Critical Care ABK254170经皮内镜胃造瘘术（PEG）套件Degania Silicone , Ltd.K242917肠内引流系统，肠内药物吸管HMC Premedical S.p.A.K250481带ENFit®连接器的扩展输注套装SKY Medical, a.s.K240052一次性肠内营养喂养套装Beijing L&Z Medical Technology Development Co., Ltd.
官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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