Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3038195661

FEI Number

3038195661

Entity Name

WELBREATH TECHNOLOGY CO.,LTD

City/State/Country

baoding Hebei, CN

Establishment Address

Room 609, building 1, No.289 Xingye Road, Baoding City,Hebei Province,China, baoding Hebei 071000, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

welbreath technology co.,ltd (Owner Number: 10093050)

Owner / Operator Contact Address

Room 609, building 1, No.289 Xingye Road, Baoding City,Hebei Province,China, baoding, CN-HE 071000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

CPAP Tubing

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CAI	Circuit, Breathing (W Connector, Adaptor, Y Piece)	Anesthesiology	Class 1	868.5240	2025-03-23
BZO	Set, Tubing And Support, Ventilator (W Harness)	Anesthesiology	Class 1	868.5975	2025-12-16
BSJ	Mask, Gas, Anesthetic	Anesthesiology	Class 1	868.5550	2025-03-23
KGB	Mask, Oxygen, Non-Rebreathing	Anesthesiology	Class 1	868.5570	2025-03-23

Official Correspondent

kevin guo

US Agent Details

Craig Meyer Email: craig@resventusa.com Phone: (913) 9087007

Related Public Records

Same Entity

welbreath technology co.,ltd

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0033-04	VIASYS Med Systems	1	Neonatal/Infant Hyperinflation Circuit, consisting of a 0.5 L breathing bag, pressure monitoring tube with Bird adapter, oxygen supply tubing, sideport connector with adjustable bleed valve, and 40 cm H2O Popoff elbow; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83124-2
Z-0034-04	VIASYS Med Systems	1	Neonatal/Infant Hyperinflation Circuit, consisting of a 0.5 L breathing bag, pressure monitoring tube, oxygen supply tubing, sideport connector with adjustable bleed valve, ported elbow and infant mask; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83100-24
Z-0035-04	VIASYS Med Systems	1	Neonatal/Infant Hyperinflation Circuit, consisting of a 0.5 L breathing bag, pressure monitoring tube, oxygen supply tubing, sideport connector with adjustable bleed valve, 40 cm H2O Popoff elbow and infant mask; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83144-24
Z-0036-04	VIASYS Med Systems	1	Hyperinflation Circuit, consisting of a 2.0 L breathing bag, pressure monitoring tube, oxygen supply tubing, sideport connector with adjustable bleed valve and ported elbow; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83120
Z-0037-04	VIASYS Med Systems	1	Sideport Kit, consisting of an adjustable sideport valve and an O2 port elbow; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83166

Similar Registrations

Registration Number	Establishment Name	Location
9680661	Mallinckrodt Dar S.r.l.	MIRANDOLA Modena, IT
2523320	Keystone Industries	Myerstown, PA, US
9616445	VADI Medical Technology Co., Ltd.	Taoyuan City, TW
3030446844	PLATINUM FOCUS GROUP LTD.	London London, City of, GB
3038562397	Respironics Medical Products (Shenzhen) Co., Ltd.	Shenzhen Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3038195661. Last updated year: 2026. Please use registration number 3038195661 when referencing this establishment in official correspondence.