Protector, Transducer, Dialysis

Which Manufacturers in China Make This?

Chinese manufacturers registered for this device type are based in Guangdong: 3 hold an FDA registration.

Bain Medical Equipment(Guangzhou) Co., Ltd. Guangdong
Guangzhou Kaiheng K&S Co., Ltd. Guangdong, contract manufacturer
Vital Healthcare (Guangzhou) Co., Ltd. Guangdong, contract manufacturer

What Is FDA Product Code FIB?

Protector, Transducer, Dialysis is FDA product code FIB, Class 2, 21 CFR 876.5820.

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. Chinese applicants hold 1 clearance under this code; the FDA took 158 days from receipt to decision.

Protector, Transducer, Dialysis

Hydromillex

2 catalogue numbers from SLST025DM, listed by Merck Millipore Ltd., Ireland, under Protector, Transducer, Dialysis. 3 manufacturers in China are registered for this product code.

Protector, Transducer, Dialysis

Nipro TP-Sure

Transducer Protector

Protector, Transducer, Dialysis

Dualex Ultra Transducer Protector

2 catalogue numbers from SLGVS25US, listed by Merck Millipore Ltd., Ireland, under Protector, Transducer, Dialysis. 3 manufacturers in China are registered for this product code.

Protector, Transducer, Dialysis

Millex – FH

2 catalogue numbers from SLFH1000N, listed by Merck Millipore Ltd., Ireland, under Protector, Transducer, Dialysis. 3 manufacturers in China are registered for this product code.

Protector, Transducer, Dialysis

Dualex Plus Transducer Protector

2 catalogue numbers from SLGVS25PS, listed by Merck Millipore Ltd., Ireland, under Protector, Transducer, Dialysis. 3 manufacturers in China are registered for this product code.

Protector, Transducer, Dialysis

ViraGuard Viral Blocking Patient Transducer Protector

Catalogue number M8-2006, listed by Medisystems Corp., United States, under Protector, Transducer, Dialysis. 3 manufacturers in China are registered for this product code.

Protector, Transducer, Dialysis

NovaLine

NovaLine model 956007 is identified in the FDA filing as a single-use transducer protector for hemodialysis delivery systems. Its stated purpose is to protect pressure monitors and help…

Protector, Transducer, Dialysis

Pall

Transducer Protector Hydrophobic Vent Filter (female and male slip luer)

Protector, Transducer, Dialysis

Dualex Transducer Protector

2 catalogue numbers from SLGVS25XS, listed by Merck Millipore Ltd., Ireland, under Protector, Transducer, Dialysis. 3 manufacturers in China are registered for this product code.

Protector, Transducer, Dialysis

Fresenius

Transducer Protectors, bulk pack

Protector, Transducer, Dialysis

Molded Products, Inc.

DIALYSIS TRANSDUCER PROTECTOR - Tamper Evident Packaging

Protector, Transducer, Dialysis

Which Manufacturers in China Make This?

What Is FDA Product Code FIB?

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

Where China Actually Supplies