Pump, Infusion

Which Manufacturers in China Make This?

4 of the 5 manufacturers in China registered for this device type are contract manufacturers, able to build to a buyer’s own specification. They are concentrated in Guangdong, Shanghai and Jiangsu.

Dongguan Honfield Precision Parts Co., Ltd. Guangdong, contract manufacturer
JDI Electronics Factory Guangdong, contract manufacturer
Sanmina Jiangsu, contract manufacturer
Sterigenics Shanghai E Beam Ltd. Shanghai, contract manufacturer
Zyno Electric & Machinery Ltd, Shanghai Shanghai, contract manufacturer

What Is FDA Product Code FRN?

Pump, Infusion is FDA product code FRN, Class 2, 21 CFR 880.5725.

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. No clearance under this code names a Chinese applicant. A registration is not a clearance: the plants above are set up to make it, and the 510(k) it is sold under is held by whoever files it, often the brand.

What Has Gone Wrong With It?

The FDA has recorded 721 recalls under this product code since 2003. None was by a company in China. 133 are Class I, the most serious grade.

The root causes the FDA records most often are Nonconforming Material/Component (134), Device Design (116) and Process control (78). A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.

Refurbished BodyGuard® Vision Pole Mount Charger

Catalogue number 150-313XVAR, listed by CME America, LLC, under Pump, Infusion. 5 manufacturers in China are registered for this product code.

Australian, Rapid Infuser, 230 V, 1000ml/min

Catalogue number 903-00024-AUS, listed by Belmont Instrument Corp., United States, under Pump, Infusion. 5 manufacturers in China are registered for this product code.

Spanish, Rapid Infuser, 230 V, 1000ml/min

Catalogue number 903-00024-S, listed by Belmont Instrument Corp., United States, under Pump, Infusion. 5 manufacturers in China are registered for this product code.

T34L Syringe Pump

Catalogue number 100-100SLA, listed by CME America, LLC, under Pump, Infusion. 5 manufacturers in China are registered for this product code.

British Military, Rapid Infuser, 230 V, 750ml/min

Catalogue number 903-00001A-BM, listed by Belmont Instrument Corp., United States, under Pump, Infusion. 5 manufacturers in China are registered for this product code.

Plum Duo Infusion System

Plum Duo Dual Channel Infusion System

Spanish, Rapid Infuser RI-2, 230v, 750 Ml/min

Catalogue number 903-00039A-S, listed by Belmont Instrument Corp., United States, under Pump, Infusion. 5 manufacturers in China are registered for this product code.

ambIT* PIB-PCA Pump

PIB-PCA Pump

Wall Charger

Catalogue number 151-143XL, listed by CME America, LLC, under Pump, Infusion. 5 manufacturers in China are registered for this product code.

Refurbished CMExpress® Pump Pole Mount Charger

Catalogue number 150-386XR, listed by CME America, LLC, under Pump, Infusion. 5 manufacturers in China are registered for this product code.

HK Klein Infiltration Pump+

HK Klein Infiltration Pump+ (KIP-II+)

Agilia VP MC Wifi US

The Agilia VP MC WiFi is a programmable volumetric infusion pump that delivers a set volume of fluid at a programmed rate. Trained healthcare professionals use it in healthcare facilities…

Swedish, Rapid Infuser, 230 V, 750ml/min

Catalogue number 903-00001A-SW, listed by Belmont Instrument Corp., United States, under Pump, Infusion. 5 manufacturers in China are registered for this product code.

Portuguese, Rapid Infuser RI-2, 230v, 750 Ml/min

Catalogue number 903-00039A-P, listed by Belmont Instrument Corp., United States, under Pump, Infusion. 5 manufacturers in China are registered for this product code.

French, Rapid Infuser, 230 V, 1000ml/min

Catalogue number 903-00024-F, listed by Belmont Instrument Corp., United States, under Pump, Infusion. 5 manufacturers in China are registered for this product code.

Slovene, Rapid Infuser, 230 V, 750ml/min

Catalogue number 903-00001A-SL, listed by Belmont Instrument Corp., United States, under Pump, Infusion. 5 manufacturers in China are registered for this product code.

3.0 Liter Reservoir (6 Count)

Catalogue number 903-00018, listed by Belmont Instrument Corp., United States, under Pump, Infusion. 5 manufacturers in China are registered for this product code.

Italian, Rapid Infuser, 230 V, 1000ml/min

Catalogue number 903-00024-I, listed by Belmont Instrument Corp., United States, under Pump, Infusion. 5 manufacturers in China are registered for this product code.

On-Body Infusor for Furoscix®

A wearable, single-use, electromechanical (battery powered, micro-processor controlled), on-body delivery system that is pre-programmed to deliver 80 mg of FUROSCIX over 5-hours using a…

Swedish, Rapid Infuser RI-2, 230v, 750 Ml/min

Catalogue number 903-00039A-SW, listed by Belmont Instrument Corp., United States, under Pump, Infusion. 5 manufacturers in China are registered for this product code.

Patient Line Extension

Catalogue number 903-00022, listed by Belmont Instrument Corp., United States, under Pump, Infusion. 5 manufacturers in China are registered for this product code.

Norwegian, Rapid Infuser, 230 V, 750ml/min

Catalogue number 903-00001A-N, listed by Belmont Instrument Corp., United States, under Pump, Infusion. 5 manufacturers in China are registered for this product code.

Dyonics

MTO Levelert Stabilizer

GemStar

PRIMARY GEMSTAR SPLIT SET Non-Vented, Extension Set with Yellow Striped Tubing, Integral PAV, 110 Inch

Alaris™ Pump Module, Model 8100

The FDA component table identifies model 8100 as the Large Volume Pump module. It lists this module separately from the Alaris Syringe Pump module, model 8110. The parent Alaris System is…

Chinese, Rapid Infuser RI-2, 230v, 750 Ml/min

Catalogue number 903-00039A-C, listed by Belmont Instrument Corp., United States, under Pump, Infusion. 5 manufacturers in China are registered for this product code.

Sapphire M.T. Infusion Kit–EGNA US

Catalogue number 17000-028-0072, listed by Eitan Medical Ltd, Israel, under Pump, Infusion. 5 manufacturers in China are registered for this product code.

T34L PCA Pump

Catalogue number 100-106SLA, listed by CME America, LLC, under Pump, Infusion. 5 manufacturers in China are registered for this product code.

Refurbished BG 323 Pump

Refurbished Pump

EZ Pump

Peristaltic Infiltration Pump

ambIT* PIB-PCA V1.5 System W/male Filter Cass

Catalogue number 220573, listed by Avanos Medical, Inc., United States, under Pump, Infusion. 5 manufacturers in China are registered for this product code.

Z-800WF

Catalogue number Z-800WF, listed by Zyno Medical LLC., United States, under Pump, Infusion. 5 manufacturers in China are registered for this product code.

Elution Test Vial

Elution Test Vial for use with CardioGen-82 Infusion System

Italian, Rapid Infuser RI-2, 230v, 750 Ml/min

Catalogue number 903-00039A-I, listed by Belmont Instrument Corp., United States, under Pump, Infusion. 5 manufacturers in China are registered for this product code.

ambIT* Continuous Pump

Continuous Pump

500ml Green Lockbox

Catalogue number 190-000XGU, listed by CME America, LLC, under Pump, Infusion. 5 manufacturers in China are registered for this product code.

Z-800

Catalogue number Z-800, listed by Zyno Medical LLC., United States, under Pump, Infusion. 5 manufacturers in China are registered for this product code.

BG 323 Pump System

Pump, battery 3600mAh, wall charger, operators manual, PCA Bolus IFU

Pump, Infusion

SOD Cann W/3POINT Olympus Interface

Sapphire MT Infusion Kit 16 – US

Catalogue number 17000-028-1039, listed by Eitan Medical Ltd, Israel, under Pump, Infusion. 5 manufacturers in China are registered for this product code.

Alaris™ PCA Module, Model 8120

Alaris™ PCA Module, Model 8120 v12.1.2

Dutch, Rapid Infuser, 230 V, 750ml/min

Catalogue number 903-00001A-D, listed by Belmont Instrument Corp., United States, under Pump, Infusion. 5 manufacturers in China are registered for this product code.

3-Spike Disposable Set

Catalogue number 903-00006, listed by Belmont Instrument Corp., United States, under Pump, Infusion. 5 manufacturers in China are registered for this product code.

APO-GO Syringe Reservoir

20 ml reservoir for Crono GO ambulatory syringe infusion pumps

Epidural Trainer Disposable Kit

EPI 6510T CompuFlo Epidural Trainer Disposable Kit

SapphirePlus Infusion Kit – US

2 catalogue numbers from 17000-033-0001, listed by Eitan Medical Ltd, Israel, under Pump, Infusion. 5 manufacturers in China are registered for this product code.

ambIT* PIB-PCA V1.5 System W/spike Filter Cass

Catalogue number 220574, listed by Avanos Medical, Inc., United States, under Pump, Infusion. 5 manufacturers in China are registered for this product code.

BodyGuard® 545 ColorVision Pump

Catalogue number 100-610XCV, listed by CME America, LLC, under Pump, Infusion. 5 manufacturers in China are registered for this product code.

Wells Johnson HVP System

Wells Johnson HVP System (High Volume Precision), 100-264VAC, 50/60Hz, 24W

Haemonetics R.I.S. System

Extension Lines

BodyGuard® 575 Pump

Pump, Battery 1800mAh, Pole-Mount Charger, Power Cord, Operator's Manual

Vario-Pedal

Vario-Pedal for Dispenser DP 30 LipoPlus

BodyGuard® 545 ColorVision® Pump System

Pump, Battery 1800mAh, Bolus Button, Pole-Mount Charger, Power Cord, Operator's Manual

Sapphire Epidural Infusion Pump Kit – US

Catalogue number 17000-031-0035, listed by Eitan Medical Ltd, Israel, under Pump, Infusion. 5 manufacturers in China are registered for this product code.

BodyGuard® 575 ColorVision® Pump System

Pump, Battery 1800mAh, Bolus Button, Pole-Mount Charger, Power Cord, Operator's Manual

BG545 With EPI28A

Catalogue number 100-743XI, listed by CME America, LLC, under Pump, Infusion. 5 manufacturers in China are registered for this product code.

Bolus Button Cable With Light

bolus cable (1)

Alaris™ Syringe Module, Model 8110

Alaris™ Syringe Module, Model 8110 v8.5.6 R

MTP

Infusion Pump

ClosureFast

Tumescent Pump Foot Pedal,Gradual Control

Portuguese, Rapid Infuser, 230 V, 1000ml/min

Catalogue number 903-00024-P, listed by Belmont Instrument Corp., United States, under Pump, Infusion. 5 manufacturers in China are registered for this product code.

German, Rapid Infuser, 230 V, 750ml/min

Catalogue number 903-00001A-G, listed by Belmont Instrument Corp., United States, under Pump, Infusion. 5 manufacturers in China are registered for this product code.

BodyGuard 575 ColorVision Pump

Catalogue number 100-620XCV, listed by CME America, LLC, under Pump, Infusion. 5 manufacturers in China are registered for this product code.

UK, Rapid Infuser, 230 V, 1000ml/min

Catalogue number 903-00024-UK, listed by Belmont Instrument Corp., United States, under Pump, Infusion. 5 manufacturers in China are registered for this product code.

Springfusor

3 catalogue numbers from Springfusor 30, listed by GO Medical Industries PTY. Ltd., Australia, under Pump, Infusion. 5 manufacturers in China are registered for this product code.

Repatha Pushtronex System, Sample

On-Body Infusor and Prefilled Cartridge, sample

Rapid Infuser Accessory Kit

Catalogue number 903-00013, listed by Belmont Instrument Corp., United States, under Pump, Infusion. 5 manufacturers in China are registered for this product code.

Sapphire M.T Infusion Pump Kit- US – S Kit

Catalogue number 17000-028-0072-S, listed by Eitan Medical Ltd, Israel, under Pump, Infusion. 5 manufacturers in China are registered for this product code.

The Belmont® Rapid Infuser FMS2000

Catalogue number 903-00001, listed by Belmont Instrument Corp., United States, under Pump, Infusion. 5 manufacturers in China are registered for this product code.

Medrad® Intego Patient Administration Set

Intego Patient Admin Set (Intego - Patient Administration Set) (60766892)

Sapphire M.T. With Bolus and Splitter Kit -US

Catalogue number 17000-028-0062, listed by Eitan Medical Ltd, Israel, under Pump, Infusion. 5 manufacturers in China are registered for this product code.

T34 Syringe Pump System

Pump, Operator's Manual

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