Device Description器械描述

Device name (trade name)器械名称（商品名）

Sterile Disposable Infusion Set

Regulatory class法规分类

Class II

Device description器械描述

Consists of a bottle spike, infusion tubing, drip chamber, flow regulator and IV needle; intended for intravenous infusion of medicinal fluids. Primary materials: PVC and ABS.

Contains software?是否含软件

Yes

No

Indications for Use适应症

Indications for use适应症声明

For clinical intravenous infusion of medicinal fluids.

Prescription / OTC处方 / OTC

Prescription Use

OTC

Substantial Equivalence实质等同论证

Substantial equivalence conclusion实质等同结论

Substantially Equivalent (SE)

Predicate device namepredicate 器械名称

Marketed Sterile Disposable Infusion Set

Predicate comparisonpredicate 对比表

Add Attachment predicate-comparison.pdf

FDA 3514 Cover Sheet封面表

Applicant Information申请人信息（6 项未填）