Medline

DBD-Mask,oxygen,hi Concen,adult,w/ 7'TUB

Registry build 21.09.26
72manufacturers in China registered for this device type
5catalogue numbers in this listing

Who Else Makes It

Concentrated in Zhejiang (25), Guangdong (14), Jiangsu (13). 15 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code KGB
Manufacturer City Province Registered as Device types
Hangzhou Rollmed Co., Ltd. Hangzhou Zhejiang Contract manufacturer 127
Guangzhou Nuoning Medical Supplies Co., Ltd. Guangzhou Guangdong Contract manufacturer 62
Amsino Medical (Kunshan) Co., Ltd. Kunshan Jiangsu Contract manufacturer 53
Flexicare Medical (Dongguan) Ltd. Dongguan Guangdong Contract manufacturer 48
Taizhou Xinkang Medical Materials Co., Ltd. Taizhou Jiangsu Contract manufacturer 35
Ningbo Luke Medical Devices Co., Ltd. Yuyao Zhejiang Contract manufacturer 27
Polymed (Xiamen) Plastic Industrial Co., Ltd. Xiamen Fujian Contract manufacturer 17
Tylenol Medical Instruments Co., Ltd. Zhongshan Guangdong Contract manufacturer 15
Nantong City Yojo Medical Products Co., Ltd. Haimen Jiangsu Contract manufacturer 14
Intersurgical Medical Apparatus (Changzhou) Co., Ltd. Changzhou Jiangsu Contract manufacturer 12
Ningbo Great Mountain Medical Instruments Co., Ltd. Ningbo Zhejiang Contract manufacturer 12
Hangzhou Jinlin Medical Appliances Co., Ltd. Hangzhou Zhejiang Contract manufacturer 11

Showing 12 of 72. All 72 manufacturers in China registered for Mask, Oxygen, Non-Rebreathing

Record

Regulatory record for Medline
Listed by Medline Industries, Inc., United States
FDA product code KGB
Device type Mask, Oxygen, Non-Rebreathing
Device class Class 1
Regulation 21 CFR 868.5570
Premarket notification Exempt
Record published 2023-01-26

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Prescription Prescription only
Latex Labelled latex-free
Label carries lot or batch number
Storage Special storage condition: Keep away from sunlight
Packaging Case of 50

Catalogue Numbers

Catalogue numbers for Medline
Catalogue number Size Status
HCSU4675B In distribution
HCSU4610B In distribution
HCS4675B In distribution
HCS4670B In distribution
HCSU4670B In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
7450 RV2 Mask Hans Rudolph, Inc. 136
6450 RV2 Mask Hans Rudolph, Inc. 23
Hudson RCI Teleflex Medical LLC 22
Mask, Oxygen, Non-Rebreathing Salter Labs 17
7400 RV2 Mask Hans Rudolph, Inc. 16
Venticaire Lite Flexicare Medical Ltd. 14
Curaplex Bound Tree Medical, LLC 12
7930 Mask Hans Rudolph, Inc. 10
8950 Mask Hans Rudolph, Inc. 10
MedSource Non-Rebreather Mask Medsource International, LLC 10
7940 Mask Hans Rudolph, Inc. 9
Resp-O2 O2 Non-Rebreather Elongated Mask Dynarex Corp. 8

Showing 12 of 139. All products under Mask, Oxygen, Non-Rebreathing

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