Filter, Infusion Line

Which Manufacturers in China Make This?

One manufacturer in China holds an FDA registration for this device type, based in Zhejiang.

Hangzhou Qiantang Longyue Biotechnology Co., Ltd. Zhejiang

What Is FDA Product Code FPB?

Filter, Infusion Line is FDA product code FPB, Class 2, 21 CFR 880.5440.

What Does It Take to Sell It in the United States?

A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. The review can be done by an FDA-accredited third party, which is usually faster. Chinese applicants hold 1 clearance under this code; the FDA took 224 days from receipt to decision.

What Has Gone Wrong With It?

The FDA has recorded 8 recalls under this product code since 2004. None was by a company in China. The root causes the FDA records most often are Process control (1) and Labeling mix-ups (1).

A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.

Filter, Infusion Line

Pall Supor® 1.2 Filter

Pall Supor 1.2 micron Air Eliminating Filter for Intravenous use. 24 hour use.

Filter, Infusion Line

Cathivex-GV

Catalogue number SLGV0250S, listed by Merck Millipore Ltd., Ireland, under Filter, Infusion Line. 1 manufacturer in China is registered for this product code.

Filter, Infusion Line

Epimed

Epidural Flat Filter

Filter, Infusion Line

Pall Supor® 5.0 Filter

Pall Supor 5.0 micron Air Eliminating Filter for Intravenous use. 24 hour use

Filter, Infusion Line

Medline Industries, Inc.

FILTER-.8 Micron

Filter, Infusion Line

WalkMed®

Pump Tubing Set with check valve and filter for WalkMed Infusion Pump, 102 cm

Filter, Infusion Line

Filter Needle for Single Use

The Filter Needle for Single Use is intended for drawing up, filtering and preparing medicinal fluid. It connects to compatible Luer-taper infusion equipment for manual fluid preparation…

Filter, Infusion Line

Fluid Systems Accessories

Air Eliminating 1.2 micrometer Solution Filter

Filter, Infusion Line

Pall® Total Nutrient Admixture Filter

1.2 micron Total Nutrient Admixture Filter with Non-Phthalate Fluid Pathway

Filter, Infusion Line

Interlink

Y-Type Blood/Solution Set with 40 and 150 Micron Dual Screen Filter and Pressure Pump, Injection Site, Male Luer Lock Adapter with Retractable Collar

Filter, Infusion Line

MedStream

FILTER-PEDIATRIC.22 Mcrn

Filter, Infusion Line

Pall Posidyne® ELD Filter

0.2 micron Intravenous Filter for 96 Hour Use with Standard bore Extension Tubing, Y injection site and luer lock adapter

Filter, Infusion Line

Spectrum, Inc.

Hydrophilic Syringe Tip Filter - DG2M-330-100, Non- Sterile

Filter, Infusion Line

Gardian 25 Mm Syringe Filter

25mm syringe filter with 5.0 micron low protein binding Versapor® membrane

Filter, Infusion Line

Pall Supor® AEF Filter

0.2 micron air eliminating filter with low protein binding Supor membrane for up to 24 hours use. Without attached extension tubing.

Filter, Infusion Line

Filter, Infusion Line

Non-DEHP MICRO-VOLUME Extension Set, 0.2 Micron Downstream Filter, Male Luer Lock Adapter

Filter, Infusion Line

Hemo-TAP

VALVE, Blood Bag Spike with StopCock

Filter, Infusion Line

Pall Posidyne® NEO Filter

Small volume 0.2 micron Air Eliminating Intravenous Filter for 96 Hour Use with Needle-free Injection Site and ultra-microbore tubing

Filter, Infusion Line

Hemo-Nate

NEEDLELESS FILTER SET, Syringe Infusion Set with a Microaggregate Blood Filter

Filter, Infusion Line

Vygon

14" STANDARDBORE EXTENSION SET WITH 0.2 MICRON FILTER AND Y-SITE (APPROX. PRIMING VOLUME 4.9 mL)

Filter, Infusion Line

Medex

44 catalogue numbers from MX815E, listed by ICU Medical, Inc, United States, under Filter, Infusion Line. 1 manufacturer in China is registered for this product code.

Filter, Infusion Line

GRI-BAG

3 catalogue numbers from 250, listed by Laboratorios Grifols SA, under Filter, Infusion Line. 1 manufacturer in China is registered for this product code.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China

2,581device types they are registered for

340,248device records, each naming its maker

31provinces with a registered manufacturer