Ventilator, Non-Continuous (Respirator)

Who Makes This Device Type in China?

9 of the 18 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 Zhejiang, and 6 other provinces.

BMC (Tianjin) Medical Co., Ltd. Tianjin, contract manufacturer
BMC Medical Co., Ltd. Beijing
BMC(Dongguan) Medical Co., Ltd. Guangdong, contract manufacturer
GaleMed (Xiamen) Co., Ltd. Fujian, contract manufacturer
Hunan Beyond Medical Technology Co., Ltd. Hunan, contract manufacturer
Mehow Innovative (Huizhou) Ltd. Guangdong, contract manufacturer
Modern Medical Equipment Manufacturing (Qing Yuan) Ltd Guangdong, contract manufacturer
Modern Medical Equipment Manufacturing Ltd. Guangdong, contract manufacturer
Ninghai Guangjie Electronic Commerce Co., Ltd. Zhejiang
Resvent Medical Technology Co., Ltd. Guangdong, contract manufacturer
Respironics Medical Products (Shenzhen) Co., Ltd. Guangdong, contract manufacturer
Shanghai Baron Technologies Co Ltd Shanghai, contract manufacturer
Shenzhen Sany Pioneer Technology Co., Ltd. Guangdong
Suzhou Avon Textile Co., Ltd. Jiangsu, contract manufacturer
Suzhou Yuyue Medical Technology Co., Ltd. Jiangsu, contract manufacturer
Sysmed (China) Co., Ltd. Liaoning
Shenzhen Wellcore Well Technology Co., Ltd. Guangdong
Zhejiang Baron Technologies Co., Ltd. Zhejiang, contract manufacturer

What Is FDA Product Code BZD?

Ventilator, Non-Continuous (Respirator) is FDA product code BZD, Class 2, 21 CFR 868.5905.

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 9 clearances under this code; the FDA took a median of 231 days from receipt to decision on them.

What Has Gone Wrong With It?

The FDA has recorded 81 recalls under this product code since 2003. None was by a company in China. 30 are Class I, the most serious grade.

The root causes the FDA records most often are Environmental control (21), Device Design (20) and Error in labeling (5). A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.

Ventilator, Non-Continuous (Respirator)

Novaplus Hospital Nasal Vented Mask, M/l

Catalogue number 50156, listed by Sleepnet Corporation, United States, under Ventilator, Non-Continuous (Respirator). 18 manufacturers in China are registered for this product code.

Ventilator, Non-Continuous (Respirator)

SleepWeaver Elan – Mask Only – Small – Pink

SleepWeaver Elan Cloth Nasal PAP Mask Only - Small - Pink

Ventilator, Non-Continuous (Respirator)

Arie Full Face Vented Mask, Small

Catalogue number 50804, listed by Sleepnet Corporation, United States, under Ventilator, Non-Continuous (Respirator). 18 manufacturers in China are registered for this product code.

Ventilator, Non-Continuous (Respirator)

ComfortGel Blue Nasal

ComfortGel Blue Nasal Mask w/Standard Elbow, w/Headgear, Petite, Japan

Ventilator, Non-Continuous (Respirator)

Drive

PillowFit Deluxe Nasal CPAP System, 1/ea

Ventilator, Non-Continuous (Respirator)

SleepWeaver Anew – Mask Only – Large – Blue

SleepWeaver Anew Cloth Full Face PAP Mask Only - Large - Blue

Ventilator, Non-Continuous (Respirator)

DreamMapper App iOS

Catalogue number 2.9, listed by Respironics Inc., United States, under Ventilator, Non-Continuous (Respirator). 18 manufacturers in China are registered for this product code.

Ventilator, Non-Continuous (Respirator)

Oxygen Port

Catalogue number 26960, listed by Resmed PTY Ltd., Australia, under Ventilator, Non-Continuous (Respirator). 18 manufacturers in China are registered for this product code.

Ventilator, Non-Continuous (Respirator)

Novaplus Hospital Nasal Vented Mask, S/m

Catalogue number 50155, listed by Sleepnet Corporation, United States, under Ventilator, Non-Continuous (Respirator). 18 manufacturers in China are registered for this product code.

Ventilator, Non-Continuous (Respirator)

DreamMapper Web (Apac)

DreamMapper Web APAC Instance v 2.11

Ventilator, Non-Continuous (Respirator)

SD Card

SD Card 10 Pack

Ventilator, Non-Continuous (Respirator)

DreamStation and System One

Humidifier Air Outlet Port Disinfection Aid

Ventilator, Non-Continuous (Respirator)

Plateau

Plateau Exhalation Valve (PEV), Single, Reusable

Ventilator, Non-Continuous (Respirator)

CPAP Carry Bag for ResMed AirSense 11

CPAP Carry Bag

Ventilator, Non-Continuous (Respirator)

FitStar Full Face Vented Mask, Medium

Catalogue number 10701, listed by Sleepnet Corporation, United States, under Ventilator, Non-Continuous (Respirator). 18 manufacturers in China are registered for this product code.

Ventilator, Non-Continuous (Respirator)

Iq Blue Nasal Mask & 6″ Tapered Tubing

Catalogue number 50293, listed by Sleepnet Corporation, United States, under Ventilator, Non-Continuous (Respirator). 18 manufacturers in China are registered for this product code.

Ventilator, Non-Continuous (Respirator)

SleepWeaver Elan – Mask Only – Small – Blue

SleepWeaver Elan Cloth Nasal PAP Mask Only - Small - Blue

Ventilator, Non-Continuous (Respirator)

V3 Full Face Vented Mask, Medium

Catalogue number 50864, listed by Sleepnet Corporation, United States, under Ventilator, Non-Continuous (Respirator). 18 manufacturers in China are registered for this product code.

Ventilator, Non-Continuous (Respirator)

ProfileLite2

Profile Lite 2 Mask with Headgear, Small, Italy

Ventilator, Non-Continuous (Respirator)

Facefit, NIV Ported Mask, With Anti-Asphyxiation Valve AND CO2 Leak Port, Medium

Facefit, NIV Ported Mask, With Anti-Asphyxiation Valve AND CO2 Leak Port, Medium Adult

Ventilator, Non-Continuous (Respirator)

Arie Full Face Vented Mask, Large

Catalogue number 50806, listed by Sleepnet Corporation, United States, under Ventilator, Non-Continuous (Respirator). 18 manufacturers in China are registered for this product code.

Ventilator, Non-Continuous (Respirator)

Large Nasal Pillows System

Catalogue number 8013, listed by Remsleep Holdings Inc, United States, under Ventilator, Non-Continuous (Respirator). 18 manufacturers in China are registered for this product code.

Ventilator, Non-Continuous (Respirator)

Mirage / UM

Mirage/UM Nasal Mask HG

Ventilator, Non-Continuous (Respirator)

Veraseal 3 Full Face Vented Mask, Small

Catalogue number 50843, listed by Sleepnet Corporation, United States, under Ventilator, Non-Continuous (Respirator). 18 manufacturers in China are registered for this product code.

Ventilator, Non-Continuous (Respirator)

RESmart® Integrated Heated Humidifier for CPAP

Catalogue number BMC-50, listed by BMC Medical Co., Ltd., China, under Ventilator, Non-Continuous (Respirator). 18 manufacturers in China are registered for this product code.

Ventilator, Non-Continuous (Respirator)

Siesta Nasal Mask Replacement Cushion-Large

Catalogue number N5B(Large), listed by BMC Medical Co., Ltd., China, under Ventilator, Non-Continuous (Respirator). 18 manufacturers in China are registered for this product code.

Ventilator, Non-Continuous (Respirator)

Vista/Kidsa

Vista/Kidsa Cushion SML

Ventilator, Non-Continuous (Respirator)

Eclipse Vent Filter Replacement Pack

Catalogue number 100662, listed by Bleep, LLC, United States, under Ventilator, Non-Continuous (Respirator). 18 manufacturers in China are registered for this product code.

Ventilator, Non-Continuous (Respirator)

SleepWeaver Anew – Mask & Headgear – Large – Blue

SleepWeaver Anew Cloth Full Face PAP Mask & Headgear - Large - Blue

Ventilator, Non-Continuous (Respirator)

Ascend Nasal Airgel Cushion Large

Catalogue number 50203, listed by Sleepnet Corporation, United States, under Ventilator, Non-Continuous (Respirator). 18 manufacturers in China are registered for this product code.

Ventilator, Non-Continuous (Respirator)

Head Strap

Catalogue number 8005, listed by Remsleep Holdings Inc, United States, under Ventilator, Non-Continuous (Respirator). 18 manufacturers in China are registered for this product code.

Ventilator, Non-Continuous (Respirator)

Humidaire 3i

HUMIDAIRE 3i CLEANING PLUG PACK

Ventilator, Non-Continuous (Respirator)

SleepWeaver 3d Mask Only – Blue

The SleepWeaver 3D Nasal Mask provides the interface between a CPAP or bi-level therapy device and a patient weighing more than 30 kg. It is intended for reuse by one patient at home or in…

Ventilator, Non-Continuous (Respirator)

SleepWeaver Elan – Mask & Headgear – Small – Beige

SleepWeaver Elan Cloth Nasal PAP Mask & Headgear - Small - Beige

Ventilator, Non-Continuous (Respirator)

Eclipse Vent Filter

Catalogue number 100671, listed by Bleep, LLC, United States, under Ventilator, Non-Continuous (Respirator). 18 manufacturers in China are registered for this product code.

Ventilator, Non-Continuous (Respirator)

Breas Isleep 20i System

Ventilator Non-continuous (Respirator)

Ventilator, Non-Continuous (Respirator)

Sunset Nasal Mask With Standard Headgear, Medium, Non-Vented Elbow

Catalogue number CM008MVNV-10, listed by Sunset Healthcare Solutions, Inc., United States, under Ventilator, Non-Continuous (Respirator). 18 manufacturers in China are registered for this product code.

Ventilator, Non-Continuous (Respirator)

Muffler

AirMini in-line muffler

Ventilator, Non-Continuous (Respirator)

Siesta Full Face Mask (SML)

Catalogue number F5A (All Size Kit), listed by BMC Medical Co., Ltd., China, under Ventilator, Non-Continuous (Respirator). 18 manufacturers in China are registered for this product code.

Ventilator, Non-Continuous (Respirator)

SleepWeaver Elan – Mask & Headgear – Regular – Beige

SleepWeaver Elan Cloth Nasal PAP Mask & Headgear - Regular - Beige

Ventilator, Non-Continuous (Respirator)

Sunset Nasal Mask With Standard Headgear, Small, Non-Vented Elbow

Catalogue number CM008SVNV-10, listed by Sunset Healthcare Solutions, Inc., United States, under Ventilator, Non-Continuous (Respirator). 18 manufacturers in China are registered for this product code.

Ventilator, Non-Continuous (Respirator)

SleepWeaver Anew – Mask & Headgear – Small – Blue

SleepWeaver Anew Cloth Full Face PAP Mask & Headgear - Small - Blue

Ventilator, Non-Continuous (Respirator)

ItAll

Replacement Full Face Mask Set with Cool-Touch Fabric Cover, Compatible with Airfit F20 & Airtouch F20 - Includes Cushion(or Mask), Frame & Headgear, No Elbow

Ventilator, Non-Continuous (Respirator)

G3 X Bpap 25a

Catalogue number G4700, listed by BMC Medical Co., Ltd., China, under Ventilator, Non-Continuous (Respirator). 18 manufacturers in China are registered for this product code.

Ventilator, Non-Continuous (Respirator)

Breas Isleep 20+ System

Ventilator Non-continuous (Respirator)

Ventilator, Non-Continuous (Respirator)

Whisper Swivel II

Catalogue number Whisper Swivel II, listed by Respironics Inc., United States, under Ventilator, Non-Continuous (Respirator). 18 manufacturers in China are registered for this product code.

Ventilator, Non-Continuous (Respirator)

DreamWear Dm Plw, Demo Pack

DreamWear Dm Plw, Demo Pack: 1 catalogue number listed by Respironics Inc., United States, under Ventilator, Non-Continuous (Respirator). 18 manufacturers in China are registered for this product code.

Ventilator, Non-Continuous (Respirator)

RESmart® Bpap System With Integrated Heated Humidifier

Catalogue number 25A (BMC-50), listed by BMC Medical Co., Ltd., China, under Ventilator, Non-Continuous (Respirator). 18 manufacturers in China are registered for this product code.

Ventilator, Non-Continuous (Respirator)

Auto CPAP System

Catalogue number Luna TravelPAP, listed by BMC Medical Co., Ltd., China, under Ventilator, Non-Continuous (Respirator). 18 manufacturers in China are registered for this product code.

Ventilator, Non-Continuous (Respirator)

Luna® CPAP System

Catalogue number E-20C-H-O, listed by BMC Medical Co., Ltd., China, under Ventilator, Non-Continuous (Respirator). 18 manufacturers in China are registered for this product code.

Ventilator, Non-Continuous (Respirator)

SleepWeaver Advance – Mask & Headgear – Blue

SleepWeaver Advance Cloth Nasal CPAP Mask & Headgear - Blue

Ventilator, Non-Continuous (Respirator)

AIR Tubing

AIR Tubing Connector

Ventilator, Non-Continuous (Respirator)

SleepWeaver Elan – Mask & Headgear – Small – Blue

SleepWeaver Elan Cloth Nasal PAP Mask & Headgear - Small - Blue

Ventilator, Non-Continuous (Respirator)

Replacement Deluxe Nasal Pillows – Medium

Sunset Healthcare Solutions Replacement Deluxe Nasal Pillows - Size Medium. Fits with Deluxe Nasal Pillow CPAP Mask Item #CM036

Ventilator, Non-Continuous (Respirator)

Mirage/ UM/ UM II

Mirage/UM/UM II Headgear Standard

Ventilator, Non-Continuous (Respirator)

FitStar Hospital Nasal Non Vented Mask, S/m

Catalogue number 50596, listed by Sleepnet Corporation, United States, under Ventilator, Non-Continuous (Respirator). 18 manufacturers in China are registered for this product code.

Ventilator, Non-Continuous (Respirator)

Vent Diffuser Kit – Quarterly Supply

Catalogue number 100593, listed by Bleep, LLC, United States, under Ventilator, Non-Continuous (Respirator). 18 manufacturers in China are registered for this product code.

Ventilator, Non-Continuous (Respirator)

Vent Filter 24 Pack

Catalogue number 100595, listed by Bleep, LLC, United States, under Ventilator, Non-Continuous (Respirator). 18 manufacturers in China are registered for this product code.

Ventilator, Non-Continuous (Respirator)

Novaplus Full Face Vented Mask, Small

Catalogue number 50867, listed by Sleepnet Corporation, United States, under Ventilator, Non-Continuous (Respirator). 18 manufacturers in China are registered for this product code.

Ventilator, Non-Continuous (Respirator)

Nasal CPAP Mask — Large

Includes 1 large sized mask, with headgear and replaceable cushion.

Ventilator, Non-Continuous (Respirator)

Dorma 100, BR

Dorma 100, Brazil

Ventilator, Non-Continuous (Respirator)

S8/ Type A

S8/TYPE A STD Filter -1 Pack

Ventilator, Non-Continuous (Respirator)

Deluxe Nasal Pillow CPAP Mask

Sunset Healthcare Solutions Deluxe Nasal Pillow CPAP Mask. Includes 1 Mask Frame with Headgear, replaceable Small, Medium and Large Nasal Pillows and SHS Labeled Bag

Ventilator, Non-Continuous (Respirator)

Ultra Mirage

Ultra Mirage Forehead Pads

Ventilator, Non-Continuous (Respirator)

Replacement Deluxe Nasal Pillows – Small

Sunset Healthcare Solutions Replacement Deluxe Nasal Pillows - Size Small. Fits with Deluxe Nasal Pillow CPAP Mask Item #CM036

Ventilator, Non-Continuous (Respirator)

Bleep Halos

Catalogue number 100590, listed by Bleep, LLC, United States, under Ventilator, Non-Continuous (Respirator). 18 manufacturers in China are registered for this product code.

Ventilator, Non-Continuous (Respirator)

SleepWeaver Advance Pediatric – Mask Only – Pink

SleepWeaver Advance Pediatric Cloth Nasal PAP Mask Only - Pink

Ventilator, Non-Continuous (Respirator)

FitStar Full Face Vented Mask, Large

Catalogue number 10702, listed by Sleepnet Corporation, United States, under Ventilator, Non-Continuous (Respirator). 18 manufacturers in China are registered for this product code.

Ventilator, Non-Continuous (Respirator)

SleepWeaver Advance – Mask & Headgear – Pink

SleepWeaver Advance Cloth Nasal CPAP Mask & Headgear - Pink

Ventilator, Non-Continuous (Respirator)

Dreamprep

Catalogue number 100433, listed by Bleep, LLC, United States, under Ventilator, Non-Continuous (Respirator). 18 manufacturers in China are registered for this product code.

Ventilator, Non-Continuous (Respirator)

Ascend Full Face Airgel Cushion, Medium

Catalogue number 50208, listed by Sleepnet Corporation, United States, under Ventilator, Non-Continuous (Respirator). 18 manufacturers in China are registered for this product code.

Ventilator, Non-Continuous (Respirator)

V3 Full Face Vented Mask, Extra Large

Catalogue number 50866, listed by Sleepnet Corporation, United States, under Ventilator, Non-Continuous (Respirator). 18 manufacturers in China are registered for this product code.

Ventilator, Non-Continuous (Respirator)

SleepWeaver Elan – Mask Only – Regular – Leopard

SleepWeaver Elan Cloth Nasal PAP Mask Only - Regular - Leopard

Ventilator, Non-Continuous (Respirator)

Ascend Full Face Airgel Cushion, Large

Catalogue number 50209, listed by Sleepnet Corporation, United States, under Ventilator, Non-Continuous (Respirator). 18 manufacturers in China are registered for this product code.

Ventilator, Non-Continuous (Respirator)

Viva Nasal Mask Replacement Cushion-Large

Catalogue number NM4(Large), listed by BMC Medical Co., Ltd., China, under Ventilator, Non-Continuous (Respirator). 18 manufacturers in China are registered for this product code.

Ventilator, Non-Continuous (Respirator)

Novaplus Pediatric Nasal Vented Mask, Large

3 catalogue numbers from 60225, listed by Sleepnet Corporation, United States, under Ventilator, Non-Continuous (Respirator). 18 manufacturers in China are registered for this product code.

Ventilator, Non-Continuous (Respirator)

SleepWeaver Advance Pediatric – Mask Only – Camo

SleepWeaver Advance Pediatric Cloth Nasal PAP Mask Only - Camo

Ventilator, Non-Continuous (Respirator)

Allied Medical LLC

Portable Assy.

Ventilator, Non-Continuous (Respirator)

Vista/Kidsta

Vista/Kidsta Headgear SML

Ventilator, Non-Continuous (Respirator)

Dream Wisp

Fitpk DreamWisp Nsl, MED Con WHGR -RTL

Ventilator, Non-Continuous (Respirator)

SleepWeaver Advance – Mask Only – Blue

SleepWeaver Advance Cloth Nasal CPAP Mask Only - Blue

Ventilator, Non-Continuous (Respirator)

Tens

TENS Electronic Pulse Stimulator for sore muscle relief

Ventilator, Non-Continuous (Respirator)

NeoPAP Bonnet – L

Catalogue number 1078538, listed by Circadiance, United States, under Ventilator, Non-Continuous (Respirator). 18 manufacturers in China are registered for this product code.

Ventilator, Non-Continuous (Respirator)

AirMini Tube

Catalogue number 38822, listed by Resmed PTY Ltd., Australia, under Ventilator, Non-Continuous (Respirator). 18 manufacturers in China are registered for this product code.

Ventilator, Non-Continuous (Respirator)

Angled Adaptor

Catalogue number 8006, listed by Remsleep Holdings Inc, United States, under Ventilator, Non-Continuous (Respirator). 18 manufacturers in China are registered for this product code.

Ventilator, Non-Continuous (Respirator)

3/16in Suction Tubing — 6ft

Catalogue number RES025-31672, listed by Sunset Healthcare Solutions, Inc., United States, under Ventilator, Non-Continuous (Respirator). 18 manufacturers in China are registered for this product code.

Ventilator, Non-Continuous (Respirator)

NeoPAP Cannula – XXS

Catalogue number 1110290, listed by Circadiance, United States, under Ventilator, Non-Continuous (Respirator). 18 manufacturers in China are registered for this product code.

Ventilator, Non-Continuous (Respirator)

3/16in Suction Tubing — 20in

Catalogue number RES025-31620, listed by Sunset Healthcare Solutions, Inc., United States, under Ventilator, Non-Continuous (Respirator). 18 manufacturers in China are registered for this product code.

Ventilator, Non-Continuous (Respirator)

DreamMapper App iOS (Emea)

DreamMapper iOS EU Instance v 2.13

Ventilator, Non-Continuous (Respirator)

Swift FX Mask SYS-SLM

Swift FX Mask System-SLM

Ventilator, Non-Continuous (Respirator)

SleepWeaver Anew – Mask Only – Regular – Blue

SleepWeaver Anew Cloth Full Face PAP Mask Only - Regular - Blue

Ventilator, Non-Continuous (Respirator)

AirMini Drawstring Bag

Catalogue number 38826, listed by Resmed PTY Ltd., Australia, under Ventilator, Non-Continuous (Respirator). 18 manufacturers in China are registered for this product code.

Ventilator, Non-Continuous (Respirator)

G3 X Bpap System

Catalogue number G4800, listed by BMC Medical Co., Ltd., China, under Ventilator, Non-Continuous (Respirator). 18 manufacturers in China are registered for this product code.

Ventilator, Non-Continuous (Respirator)

Innova Hospital Nasal Non Vented Mask, M/l

Catalogue number 50595, listed by Sleepnet Corporation, United States, under Ventilator, Non-Continuous (Respirator). 18 manufacturers in China are registered for this product code.

Ventilator, Non-Continuous (Respirator)

ClimateLineAir 11 Oxy

Climatelineair 11 OXY - AME

Ventilator, Non-Continuous (Respirator)

Vpapiii

A/ST-A/S SPIRIT-S7E-VPAPIII Cable

Ventilator, Non-Continuous (Respirator)

DreamStation Expert

DreamStation Expert with Humidifier, WiFi, France

Ventilator, Non-Continuous (Respirator)

Novaplus Pediatric Nasal Vented Mask, Medium

2 catalogue numbers from 60224, listed by Sleepnet Corporation, United States, under Ventilator, Non-Continuous (Respirator). 18 manufacturers in China are registered for this product code.

Ventilator, Non-Continuous (Respirator)

Sunset Nasal Mask With Standard Headgear, Large, Non-Vented Elbow

Catalogue number CM008LVNV-10, listed by Sunset Healthcare Solutions, Inc., United States, under Ventilator, Non-Continuous (Respirator). 18 manufacturers in China are registered for this product code.

Ventilator, Non-Continuous (Respirator)

Veraseal 3 Full Face Vented Mask, Medium

Catalogue number 50844, listed by Sleepnet Corporation, United States, under Ventilator, Non-Continuous (Respirator). 18 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