Search Results
Found 1 results
510(k) Data Aggregation
K Number
K210381Device Name
I.V. Administration Set
Manufacturer
BQ PLUS Medical Co., Ltd.
Date Cleared
2021-08-14
(186 days)
Product Code
FPA
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
BQ PLUS Medical Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The I.V. Administration Set intended use is to deliver sterile, infusion fluid from a container to the patient with or without flow control features.
The I.V. Extension Set may act as an extension of other infusion tubing intravenous fluids from a container to patient.
Device Description
The propose device, I.V. Administration Set, is a single used device. It has seven models. The models and their features are listed in Table 1. There are seven different models, each configuration comprise of various components which may include: IV Chamber, Tubing, Roller Clamp, Y Site, Needle Free Valve, Slide Clamp, Back Check Valve, Male Luer Lock, 3 Way Stop Cock, Female Luer Lock, Flow Regulator, Rotating Luer Lock, T-Connector, Luer Lock Cap, Hanger, Drop, Female Luer Connector and Cap. The devices are provided sterile and single use. The proposed devices are sterilized by EO to achieve a SAL 10-6 and supplied in sterility maintenance package which could maintain the sterility of the device during the shelf life of 3 years.
Ask a Question
Page 1 of 1