Ventilator, Continuous, Facility Use

Who Makes This Device Type in China?

6 of the 8 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, Jiangsu and Fujian, and 1 other province.

Beijing Aeonmed Co., Ltd. Hebei, contract manufacturer
GE Medical Systems (China) Co., Ltd. Jiangsu, contract manufacturer
GaleMed (Xiamen) Co., Ltd. Fujian, contract manufacturer
Mehow Innovative (Huizhou) Ltd. Guangdong, contract manufacturer
Respironics Medical Products (Shenzhen) Co., Ltd. Guangdong, contract manufacturer
Shenzhen Mindray BIO-Medical Electronics Co., Ltd. Guangdong
Sanmina Jiangsu, contract manufacturer
Vincent Medical (Dong Guan) Manufacturing Co., Ltd. Guangdong, contract manufacturer

What Is FDA Product Code CBK?

Ventilator, Continuous, Facility Use is FDA product code CBK, Class 2, 21 CFR 868.5895.

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 2 clearances under this code; the FDA took a median of 392 days from receipt to decision on them.

What Has Gone Wrong With It?

The FDA has recorded 323 recalls under this product code since 2001. None was by a company in China. 157 are Class I, the most serious grade.

The root causes the FDA records most often are Device Design (62), Software design (47) and Nonconforming Material/Component (25). A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.

Ventilator, Continuous, Facility Use

High Pressure Hose Heliox Diss 5m

Catalogue number 6675592, listed by Maquet Critical Care AB, Sweden, under Ventilator, Continuous, Facility Use. 8 manufacturers in China are registered for this product code.

Ventilator, Continuous, Facility Use

Carrier SERVO-i, Robust, Flatpack

Catalogue number 6671675, listed by Maquet Critical Care AB, Sweden, under Ventilator, Continuous, Facility Use. 8 manufacturers in China are registered for this product code.

Ventilator, Continuous, Facility Use

Mask NovaStarTS,NIV,w/AAV,L

Catalogue number MP01578, listed by Drägerwerk AG & Co. KGaA, Germany, under Ventilator, Continuous, Facility Use. 8 manufacturers in China are registered for this product code.

Ventilator, Continuous, Facility Use

Neonatal Flow Sensor, Y-Piece

Catalogue number 8410185, listed by Drägerwerk AG & Co. KGaA, Germany, under Ventilator, Continuous, Facility Use. 8 manufacturers in China are registered for this product code.

Ventilator, Continuous, Facility Use

Patient Circuit Kit

Catalogue number Patient Circuit Kit, listed by Corvent Medical Inc., United States, under Ventilator, Continuous, Facility Use. 8 manufacturers in China are registered for this product code.

Ventilator, Continuous, Facility Use

GAS Cylinder Restrainer KIT

Catalogue number 6693720, listed by Maquet Critical Care AB, Sweden, under Ventilator, Continuous, Facility Use. 8 manufacturers in China are registered for this product code.

Ventilator, Continuous, Facility Use

ResMed

Astral PSU SlimLine

Ventilator, Continuous, Facility Use

Flow Sensor Cable

Catalogue number Flow Sensor Cable, listed by Corvent Medical Inc., United States, under Ventilator, Continuous, Facility Use. 8 manufacturers in China are registered for this product code.

Ventilator, Continuous, Facility Use

Pneuton Model a With 6ft Patient Circuit

58051 - 6 ft. Patient Circuit,

Ventilator, Continuous, Facility Use

Lint Filters

Catalogue number Lint Filters, listed by Corvent Medical Inc., United States, under Ventilator, Continuous, Facility Use. 8 manufacturers in China are registered for this product code.

Ventilator, Continuous, Facility Use

Cart, Display Bracket

Catalogue number Cart, Display Bracket, listed by Corvent Medical Inc., United States, under Ventilator, Continuous, Facility Use. 8 manufacturers in China are registered for this product code.

Ventilator, Continuous, Facility Use

VentStar Oxylog3000F,2000p 300

Catalogue number MP00335, listed by Drägerwerk AG & Co. KGaA, Germany, under Ventilator, Continuous, Facility Use. 8 manufacturers in China are registered for this product code.

Ventilator, Continuous, Facility Use

Hsiner

NIPPV Silicone Face mask set

Ventilator, Continuous, Facility Use

Patient Circuit – Pediatric, 2.4m, 1 Pcs

Catalogue number VWSP-390, listed by Inovytec Medical Solutions Ltd., Israel, under Ventilator, Continuous, Facility Use. 8 manufacturers in China are registered for this product code.

Ventilator, Continuous, Facility Use

Trilogy 206

Trilogy100 Ventilator, Rental, International version

Ventilator, Continuous, Facility Use

Respond Power Supply (US)

Catalogue number RESPOND Power Supply (US), listed by Corvent Medical Inc., United States, under Ventilator, Continuous, Facility Use. 8 manufacturers in China are registered for this product code.

Ventilator, Continuous, Facility Use

etCO2 Airway Adapter Neonatal Disp. 1pcs

Catalogue number 6884536, listed by Maquet Critical Care AB, Sweden, under Ventilator, Continuous, Facility Use. 8 manufacturers in China are registered for this product code.

Ventilator, Continuous, Facility Use

Servo-S Base Unit

Catalogue number 6640440, listed by Maquet Critical Care AB, Sweden, under Ventilator, Continuous, Facility Use. 8 manufacturers in China are registered for this product code.

Ventilator, Continuous, Facility Use

Patient Circuit Arm Clip

Catalogue number Patient Circuit Arm Clip, listed by Corvent Medical Inc., United States, under Ventilator, Continuous, Facility Use. 8 manufacturers in China are registered for this product code.

Ventilator, Continuous, Facility Use

LTV 1150 Ventilator

Assy, LTV1150, W/ Access, English

Ventilator, Continuous, Facility Use

Gas Cylinder Restrainer Servo-S

Following Device Identifier is including in this KIT: 07325710003152

Ventilator, Continuous, Facility Use

Flow Sensor

Flow Sensor for VM-2XXX Series HeroVent Emergency and Transport ventilators.

Ventilator, Continuous, Facility Use

PTV

Assy, PKG, Enve, GRN, Diss, English

Ventilator, Continuous, Facility Use

Veraseal 3 Full Face AAV Non Vented Mask, Medium

Catalogue number 50954, listed by Sleepnet Corporation, United States, under Ventilator, Continuous, Facility Use. 8 manufacturers in China are registered for this product code.

Ventilator, Continuous, Facility Use

Inlet Filter for VM-2000

Inlet Filter for VM-2XXX Series HeroVent Emergency and Transport ventilators.

Ventilator, Continuous, Facility Use

BiPAP A40 EFL

Trilogy Ventilator - Active Flow Exhalation Patient Circuit, Adult

Ventilator, Continuous, Facility Use

BV Filters

Catalogue number BV Filters, listed by Corvent Medical Inc., United States, under Ventilator, Continuous, Facility Use. 8 manufacturers in China are registered for this product code.

Ventilator, Continuous, Facility Use

Model EMV+ Vent, Army, MRI

Catalogue number 799-EMVP-04-66, listed by Zoll Medical Corporation, United States, under Ventilator, Continuous, Facility Use. 8 manufacturers in China are registered for this product code.

Ventilator, Continuous, Facility Use

IV Pole

Catalogue number 6481738, listed by Maquet Critical Care AB, Sweden, under Ventilator, Continuous, Facility Use. 8 manufacturers in China are registered for this product code.

Ventilator, Continuous, Facility Use

Savina System

Catalogue number 8414450, listed by Drägerwerk AG & Co. KGaA, Germany, under Ventilator, Continuous, Facility Use. 8 manufacturers in China are registered for this product code.

Ventilator, Continuous, Facility Use

Life2000

Breathe LIFE2000 Ventilator Package Hospital

Ventilator, Continuous, Facility Use

Patient Circuit – Adult, 1.8m, 1 Pcs, One Way

Catalogue number VWSP-450F, listed by Inovytec Medical Solutions Ltd., Israel, under Ventilator, Continuous, Facility Use. 8 manufacturers in China are registered for this product code.

Ventilator, Continuous, Facility Use

Evolution

Evolution: 1 catalogue number listed by Event Medical, Ltd., United States, under Ventilator, Continuous, Facility Use. 8 manufacturers in China are registered for this product code.

Ventilator, Continuous, Facility Use

Cart SERVO-s, Flatpack

Catalogue number 6650506, listed by Maquet Critical Care AB, Sweden, under Ventilator, Continuous, Facility Use. 8 manufacturers in China are registered for this product code.

Ventilator, Continuous, Facility Use

Edi Cath. 12fr/125cm 1/pkg

Catalogue number 6686410, listed by Maquet Critical Care AB, Sweden, under Ventilator, Continuous, Facility Use. 8 manufacturers in China are registered for this product code.

Ventilator, Continuous, Facility Use

Flow Sensor Reusable

Flow Sensor Reusable for VM-2XXX Series HeroVent Emergency and Transport ventilators.

Ventilator, Continuous, Facility Use

Base Unit, Servo-Air

Catalogue number 6882000, listed by Maquet Critical Care AB, Sweden, under Ventilator, Continuous, Facility Use. 8 manufacturers in China are registered for this product code.

Ventilator, Continuous, Facility Use

Base Unit Servo-U MR

The Servo-u MR base unit supplies respiratory support as part of the Servo-u MR ventilator system for neonatal, pediatric and adult patients. It is used by healthcare providers in…

Ventilator, Continuous, Facility Use

User Interface Holder

Catalogue number 6880099, listed by Maquet Critical Care AB, Sweden, under Ventilator, Continuous, Facility Use. 8 manufacturers in China are registered for this product code.

Ventilator, Continuous, Facility Use

Mask ClassicStar,NIV,w/AAV,M

Catalogue number MP01571, listed by Drägerwerk AG & Co. KGaA, Germany, under Ventilator, Continuous, Facility Use. 8 manufacturers in China are registered for this product code.

Ventilator, Continuous, Facility Use

Pendant BED/Holder

Sales kit containing 1pc Universal holder 07325710004289 1 pc Table attachement 07325710004272

Ventilator, Continuous, Facility Use

Gas Cylinder Restrainer Assy

Catalogue number 6883880, listed by Maquet Critical Care AB, Sweden, under Ventilator, Continuous, Facility Use. 8 manufacturers in China are registered for this product code.

Ventilator, Continuous, Facility Use

Clamp 1 Slot

Catalogue number 9358193, listed by Maquet Critical Care AB, Sweden, under Ventilator, Continuous, Facility Use. 8 manufacturers in China are registered for this product code.

Ventilator, Continuous, Facility Use

Mask ClassicStar Nasal NV, M

Catalogue number MP01624, listed by Drägerwerk AG & Co. KGaA, Germany, under Ventilator, Continuous, Facility Use. 8 manufacturers in China are registered for this product code.

Ventilator, Continuous, Facility Use

Vocsn O2 Low Pressure Inlet

VOCSN O2 Low Pressure Inlet, 10-Pack

Ventilator, Continuous, Facility Use

Servo-I Holder

Catalogue number 6671717, listed by Maquet Critical Care AB, Sweden, under Ventilator, Continuous, Facility Use. 8 manufacturers in China are registered for this product code.

Ventilator, Continuous, Facility Use

Astral 100

Astral 100 - Refurbished

Ventilator, Continuous, Facility Use

Humidifier Holder

Sales kit containing: 1 pc Humidification holder assembly 07325710004258 1 pc Rail clamp 07325710004265

Ventilator, Continuous, Facility Use

Cabinet

Catalogue number 6882074, listed by Maquet Critical Care AB, Sweden, under Ventilator, Continuous, Facility Use. 8 manufacturers in China are registered for this product code.

Ventilator, Continuous, Facility Use

Y Sensor Neonatal, Disposable, 5 Pcs/pkg

Catalogue number 6693667, listed by Maquet Critical Care AB, Sweden, under Ventilator, Continuous, Facility Use. 8 manufacturers in China are registered for this product code.

Ventilator, Continuous, Facility Use

etCO2 Airway Adapter Adult Disp. 1pcs

Catalogue number 6884526, listed by Maquet Critical Care AB, Sweden, under Ventilator, Continuous, Facility Use. 8 manufacturers in China are registered for this product code.

Ventilator, Continuous, Facility Use

Aeroneb Module Pro Kit, SERVO-i

Following Device Identifier numbers are included in this KIT: 07325710002841, 07325710004807

Ventilator, Continuous, Facility Use

Oxygen Enrichment Kit

Oxygen Enrichment Kit for VM-2XXX Series HeroVent Emergency and Transport ventilators

Ventilator, Continuous, Facility Use

Respond Ventilator Kit

The RESPOND Ventilator Kit provides mechanical breathing support through continuous or intermittent positive pressure ventilation. It is intended for pediatric and adult patients weighing…

Ventilator, Continuous, Facility Use

Carina System

Catalogue number 8419350, listed by Drägerwerk AG & Co. KGaA, Germany, under Ventilator, Continuous, Facility Use. 8 manufacturers in China are registered for this product code.

Ventilator, Continuous, Facility Use

Primary Battery for VM-2000

Battery pack for VM-2XXX Series HeroVent Emergency and Transport ventilators.

Ventilator, Continuous, Facility Use

Edi Module Cable With Test Plug

Catalogue number 6671960, listed by Maquet Critical Care AB, Sweden, under Ventilator, Continuous, Facility Use. 8 manufacturers in China are registered for this product code.

Ventilator, Continuous, Facility Use

FitStar Full Face AAV Non Vented Mask, Small

Catalogue number 10708, listed by Sleepnet Corporation, United States, under Ventilator, Continuous, Facility Use. 8 manufacturers in China are registered for this product code.

Ventilator, Continuous, Facility Use

LTV 1150 Ventilator

LTV 1150 Ventilator, English

Ventilator, Continuous, Facility Use

Veraseal 2 Full Face AAV Non Vented Mask, Extra Large

2 catalogue numbers from 50940, listed by Sleepnet Corporation, United States, under Ventilator, Continuous, Facility Use. 8 manufacturers in China are 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