Roscoe

Oxygen Mask (Adult) Medium Concentration, 7’ (2.1 m) supply tube, elastic strap

Registry build 21.09.26
126manufacturers in China registered for this device type
32catalogue 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 Roscoe
Listed by Drive DeVilbiss Healthcare, United States
FDA product code BYG
Device type Mask, Oxygen
Device class Class 1
Regulation 21 CFR 868.5580
Establishment Repacker / relabeller
Premarket notification Exempt
Record published 2022-12-12
Record revised 2026-05-27 (version 3)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Prescription Prescription only
Over the counter Yes
Label carries lot or batch number, expiry date, manufacturing date

Catalogue Numbers

Catalogue numbers for Roscoe
Catalogue number Size Status
90613 In distribution
ROS-T09M In distribution
90089 In distribution
90617 In distribution
90377 In distribution
90609 In distribution
90605 In distribution
X1DEF2HS03 In distribution
90615 In distribution
X1DEF2HS05 In distribution
X1DEF2HS04 In distribution
90108 In distribution
90112 In distribution
90611 In distribution
90110 In distribution
90091 In distribution
X1DEF2HS02 In distribution
X1GOSH04 In distribution
PED-MASK In distribution
70146 In distribution
70120 In distribution
90093 In distribution
90607 In distribution
90087 In distribution
ADLT-MASK In distribution
ROS-1012911 In distribution
CPH-RESCHIN In distribution
X1GOSH02 In distribution
90095 In distribution
O2MASK-ADULT In distribution
X1DEF2HS01 In distribution
X1GOSH03 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
Curaplex Bound Tree Medical, LLC 33
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