Set, Tubing, Blood, With and Without Anti-Regurgitation Valve

Who Makes This Device Type in China?

5 manufacturers in China hold an FDA registration for this device type, concentrated in Guangdong, Jiangxi and Zhejiang.

Bain Medical Equipment(Guangzhou) Co., Ltd. Guangdong
Guangzhou Kaiheng K&S Co., Ltd. Guangdong, contract manufacturer
Jiangxi Sanxin Medtec Co., Ltd. Jiangxi
Ningbo Tianyi Medical Appliance Co., Ltd. Zhejiang, contract manufacturer
Vital Healthcare (Guangzhou) Co., Ltd. Guangdong, contract manufacturer

What Is FDA Product Code FJK?

Set, Tubing, Blood, With And Without Anti-Regurgitation Valve is FDA product code FJK, Class 2, 21 CFR 876.5820.

How Does It Reach the US Market?

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 5 clearances under this code; the FDA took a median of 287 days from receipt to decision on them.

What Do the Recalls Say?

The FDA has recorded 35 recalls under this product code since 2007. None was by a company in China. 7 are Class I, the most serious grade.

The root causes the FDA records most often are Device Design (16) and Process control (12). A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.

Set, Tubing, Blood, With And Without Anti-Regurgitation Valve

07103300/s

Recirculating FLL connector with protective vented cap and closed cap

Set, Tubing, Blood, With And Without Anti-Regurgitation Valve

Streamline Airless System Set With Locksite Needleless Access Sites

2 catalogue numbers from SL-2000M2095W, listed by Nxstage Medical, Inc., United States, under Set, Tubing, Blood, With And Without Anti-Regurgitation Valve. 5 manufacturers in China are registered for this product code.

Set, Tubing, Blood, With And Without Anti-Regurgitation Valve

BD Blood Pump Transfusion Set

Blood Transfusion Set

Set, Tubing, Blood, With And Without Anti-Regurgitation Valve

Lifemed 60 Inch Monitor Line

60 inch (152 cm) Monitor Line

Set, Tubing, Blood, With And Without Anti-Regurgitation Valve

Piranha

ROTATIONS-MORCELLATOR Ø 4.8MM WL 385MM for MORCESCOPE Storz, for morcellation following laser prostate enucleation, sterile

Set, Tubing, Blood, With And Without Anti-Regurgitation Valve

Fresenius

Recirculation connector, bulk pack

Set, Tubing, Blood, With And Without Anti-Regurgitation Valve

SaniGuard

Non-injectable Catheter Cap

Set, Tubing, Blood, With And Without Anti-Regurgitation Valve

Tablo Needleless Cartridge, B

Tablo Cartridge with Needleless Infusion Ports Type B

Set, Tubing, Blood, With And Without Anti-Regurgitation Valve

AMSafe® 94″ (239cm) Y-Type Blood Set

AMSafe® 94" (239cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, MicroClave® Clear, Rotating Luer, Approx Priming Volume: 57.2mL

Set, Tubing, Blood, With And Without Anti-Regurgitation Valve

Dora

Catalogue number BAIN-BL-002E, listed by Bain Medical Equipment(Guangzhou) Co., Ltd., China, under Set, Tubing, Blood, With And Without Anti-Regurgitation Valve. 5 manufacturers in China are registered for this product code.

Set, Tubing, Blood, With And Without Anti-Regurgitation Valve

CAREline

Catalogue number 0342006, listed by Fresenius Medical Care Renal Therapies Group, LLC, United States, under Set, Tubing, Blood, With And Without Anti-Regurgitation Valve. 5 manufacturers in China are registered for this product code.

Set, Tubing, Blood, With And Without Anti-Regurgitation Valve

Tablo Hemodialysis Concentrate

Liquid acid concentrate, 45X, 1K, 2.5Ca, 1 U.S. gallon

Set, Tubing, Blood, With And Without Anti-Regurgitation Valve

Blood Tube Set

Quanta Dialysis System Blood Tube Set

Set, Tubing, Blood, With And Without Anti-Regurgitation Valve

Lifemed Low Volume Tubing Set

Low Volume Tubing Set

Set, Tubing, Blood, With And Without Anti-Regurgitation Valve

AMSafe® 105″ (267cm) Y-Type Blood Set

AMSafe® 105" (267cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Pre-Slit Port, MicroClave® Clear, Rotating Luer, 1 Ext, Approx Priming Volume: 59.3mL

Set, Tubing, Blood, With And Without Anti-Regurgitation Valve

Slimline™ Blood Tubing SET With Transducer Protectors AND Priming SET

PUMP SEGMENT 8.0 mm PRIMING VOLUME 119 ML EQUIPMENT FRESENIUS 2008H, K, K2, T

Set, Tubing, Blood, With And Without Anti-Regurgitation Valve

Vital

The filing identifies the VITAL Tubing Sets for Hemodialysis as sterile, single-use arterial and venous blood lines. The filing lists BLU001E, BLU004E and BLU008E among its proposed models.

Set, Tubing, Blood, With And Without Anti-Regurgitation Valve

Lifemed Male to Male Luer Adapter

Male to Male Luer Adapter

Set, Tubing, Blood, With And Without Anti-Regurgitation Valve

Set, Tubing, Blood, With and Without Anti-Regurgitation Valve

GMB-SP127 Accessory Y connector

Set, Tubing, Blood, With And Without Anti-Regurgitation Valve

Set, Tubing, Blood, With and Without Anti-Regurgitation Valve

Extracorporeal Blood Tubing Set

Set, Tubing, Blood, With And Without Anti-Regurgitation Valve

B.braun

Bloodline Extension Set (3 ft tubing)

Set, Tubing, Blood, With And Without Anti-Regurgitation Valve

AMSafe® 102″ (259cm) Y-Type Blood Set

AMSafe® 102" (259cm) Y-Type Blood Set w/210 Micron Filter, MicroClave® Clear, Rotating Luer, Approx Priming Volume: 20.2mL

Set, Tubing, Blood, With And Without Anti-Regurgitation Valve

Fresenius HemaClip

Bloodline Connector Clip. For CombiSet Bloodlines only

Set, Tubing, Blood, With And Without Anti-Regurgitation Valve

Recirculation Adapter/Priming Connector

This blood tubing set accessory is intended for single use in a hemodialysis treatment. It may be used either as a recirculation adapter during use to connect the arterial and venous…

Set, Tubing, Blood, With And Without Anti-Regurgitation Valve

CombiSet

Pre-pump, 6.35 mm, low volume

Set, Tubing, Blood, With And Without Anti-Regurgitation Valve

NovaLine

5 catalogue numbers from BL 124, listed by Bain Medical Equipment(Guangzhou) Co., Ltd., China, under Set, Tubing, Blood, With And Without Anti-Regurgitation Valve. 5 manufacturers in China are registered for this product code.

Set, Tubing, Blood, With And Without Anti-Regurgitation Valve

CAREline

Catalogue number 0342501, listed by Fresenius Medical Care, United States, under Set, Tubing, Blood, With And Without Anti-Regurgitation Valve. 5 manufacturers in China are registered for this product code.

Set, Tubing, Blood, With And Without Anti-Regurgitation Valve

Tablo Cartridge

Tablo Cartridge with Needleless Infusion Ports

Set, Tubing, Blood, With And Without Anti-Regurgitation Valve

Plasma Exchange Tubeset

2 catalogue numbers from 064I, listed by Asahi Kasei Medical America Inc., under Set, Tubing, Blood, With And Without Anti-Regurgitation Valve. 5 manufacturers in China are registered for this product code.

Set, Tubing, Blood, With And Without Anti-Regurgitation Valve

Sunder

The S-01-K51-F-01 is primarily intended for patients with renal diseases, such as chronic renal failure and uremia, who require hemodialysis treatment.

Set, Tubing, Blood, With And Without Anti-Regurgitation Valve

Diapact®

CWHD/CWHFD Tubing Set (unassembled)

Set, Tubing, Blood, With And Without Anti-Regurgitation Valve

Hemodialysis Bloodlines

Streamline® Bloodline Set for Dialog+® Hemodialysis System

Set, Tubing, Blood, With And Without Anti-Regurgitation Valve

Tablo(R) Cartridge

The Tablo Cartridge is a single use, disposable arterial and venous bloodline set intended to provide extracorporeal access during hemodialysis.

Set, Tubing, Blood, With And Without Anti-Regurgitation Valve

Cartridge Blood Set

The Gambro Cartridge Blood Set is intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery System from Rev. SW 3.40. The Low Weight - Low Volume model is used…

Set, Tubing, Blood, With And Without Anti-Regurgitation Valve

Tablo(R) Straws

Straws, for concentrate bottles

Set, Tubing, Blood, With And Without Anti-Regurgitation Valve

5008x

5008X Venous Pressure Replacement Line with Transducer Protector

Set, Tubing, Blood, With And Without Anti-Regurgitation Valve

Oxyless

The Oxyless blood tubing set comprises disposable blood tubing lines intended to provide extra-corporeal access to the patient's blood during hemodialysis.

Set, Tubing, Blood, With And Without Anti-Regurgitation Valve

Blood Circuit SET

Single Needle Expansion Chamber

Set, Tubing, Blood, With And Without Anti-Regurgitation Valve

Lifemed Tubing Recirculating Set

Tubing Recirculating Set

Set, Tubing, Blood, With And Without Anti-Regurgitation Valve

Medisystems Hemodialysis Blood Tubing Sets

4 catalogue numbers from B3-6605M6792, listed by Medisystems Corp., United States, under Set, Tubing, Blood, With And Without Anti-Regurgitation Valve. 5 manufacturers in China are registered for this product code.

Set, Tubing, Blood, With And Without Anti-Regurgitation Valve

Streamline Airless System Set With Locksite Needleless Access Sites

5 catalogue numbers from SL-2000M2095, listed by Medisystems Corp., United States, under Set, Tubing, Blood, With And Without Anti-Regurgitation Valve. 5 manufacturers in China are registered for this product code.

Set, Tubing, Blood, With And Without Anti-Regurgitation Valve

Nipro SET Blood Tubing SET With Transducer Protectors AND Priming SET

PUMP SEGMENT 8.0mm PRIMING VOLUME 144 ML EQUIPMENT BAXTER 1000/BAXTER ARENA

Set, Tubing, Blood, With And Without Anti-Regurgitation Valve

Tablo(R) Disinfectant Straws

Straws for disinfectant bottle

Set, Tubing, Blood, With And Without Anti-Regurgitation Valve

RPC

Recirculation Connector

Set, Tubing, Blood, With And Without Anti-Regurgitation Valve

ICU Medical

130" (330 cm) Y-Type Blood Set w/170 Micron Filter, 2 Y-Connectors w/Check Valves, Remv 3 Gang 1o2™ Manifold, Check Valve, Rotating Luer, 1 Ext

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