Curaplex

Curaplex Oxygen Mask, Adult, Elongated, High Conc, Partial NRB, Metal Noseclip, Reservoir Bag 50ea/cs

Registry build 21.09.26
126manufacturers in China registered for this device type
33catalogue numbers in this listing

Who Else Makes It

Concentrated in Zhejiang (40), Guangdong (29), Jiangsu (23). 24 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code BYG
Manufacturer City Province Registered as Device types
Hangzhou Rollmed Co., Ltd. Hangzhou Zhejiang Contract manufacturer 127
Shanghai Joy Crown Industry Co., Ltd. Pu Dong New Area Shanghai Contract manufacturer 64
Nanning Tecbod Biological Technology Co., Ltd. Nanning Guangxi Contract manufacturer 51
Flexicare Medical (Dongguan) Ltd. Dongguan Guangdong Contract manufacturer 48
Evereast Medical Products Group Co., Ltd. Changyuan Henan Contract manufacturer 30
Vincent Medical (Dong Guan) Manufacturing Co., Ltd. Dong Guan Guangdong Contract manufacturer 29
Ningbo Luke Medical Devices Co., Ltd. Yuyao Zhejiang Contract manufacturer 27
Changzhou Recoo Healthcare Co., Ltd. Changzhou Jiangsu Contract manufacturer 19
Sunmed AP, Ltd. Zhuhai Guangdong Contract manufacturer 18
Polymed (Xiamen) Plastic Industrial Co., Ltd. Xiamen Fujian Contract manufacturer 17
Hitec Medical Co., Ltd. Shanghai Shanghai Contract manufacturer 17
Sunmed AP, Ltd., Warehouse NO. 2 Zhuhai Guangdong Contract manufacturer 16

Showing 12 of 126. All 126 manufacturers in China registered for Mask, Oxygen

Record

Regulatory record for Curaplex
Listed by Bound Tree Medical, LLC, United States
FDA product code BYG
Device type Mask, Oxygen
Device class Class 1
Regulation 21 CFR 868.5580
Establishment Manufacturer
Premarket notification Exempt
Record published 2022-12-30
Record revised 2023-12-29 (version 6)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Ethylene Oxide
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Over the counter Yes
Supplied as a kit Yes
Latex Labelled latex-free
Label carries lot or batch number, expiry date, manufacturing date
Packaging Case of 50, pack of 50, case of 30, case of 100, case of 40, case of 3
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Curaplex
Catalogue number Size Status
36276 In distribution
301-181U In distribution
36275 In distribution
36279 In distribution
8600-01360 In distribution
301-182U In distribution
301-184 In distribution
301-183 In distribution
36274 In distribution
301-180EA In distribution
36277 In distribution
533-MS-25058EA In distribution
301-180U In distribution
533-MS-25060EA In distribution
36278 In distribution
30053 In distribution
30051 In distribution
301-189 In distribution
533-MS-25058EA In distribution
301-180EA In distribution
533-MS-25058EA In distribution
301-181EA In distribution
301-170EA In distribution
301-PASC107 In distribution
301-189U In distribution
30052 In distribution
301-191 In distribution
301-182EA In distribution
301-181EA In distribution
30054 In distribution
301-160EA In distribution
301-192 In distribution
355-3222-EEA In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Hudson RCI Teleflex Medical LLC 87
Mask, Oxygen Salter Labs 61
Curaplex TRI-Anim Health Services, Inc. 34
7301 EAGLE1 Hans Rudolph, Inc. 33
Roscoe Drive DeVilbiss Healthcare 32
BF Allied Medical LLC 28
Ventlab Ventlab, LLC 25
Adsafe™ American Diagnostic Corp. 25
7302 EAGLE2 Hans Rudolph, Inc. 24
Oxygen Mask Well Lead Medical Co., Ltd. 24
AirLife™ Airlife, Inc. 21
Procure Twin Med, LLC 19

Showing 12 of 302. All products under Mask, Oxygen

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

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