ASP Medical

Disposable AIR Cushion Mask, Valve ON TOP, Size 1, 1/EA

Registry build 21.09.26
71manufacturers in China registered for this device type
7catalogue numbers in this listing

Who Else Makes It

Concentrated in Zhejiang (27), Guangdong (16), Jiangsu (8). 17 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code BSJ
Manufacturer City Province Registered as Device types
Hangzhou Rollmed Co., Ltd. Hangzhou Zhejiang Contract manufacturer 127
Flexicare Medical (Dongguan) Ltd. Dongguan Guangdong Contract manufacturer 48
Ningbo Luke Medical Devices Co., Ltd. Yuyao Zhejiang Contract manufacturer 27
Sunmed AP, Ltd. Zhuhai Guangdong Contract manufacturer 18
Polymed (Xiamen) Plastic Industrial Co., Ltd. Xiamen Fujian Contract manufacturer 17
Sunmed AP, Ltd., Warehouse NO. 2 Zhuhai Guangdong Contract manufacturer 16
Tylenol Medical Instruments Co., Ltd. Zhongshan Guangdong Contract manufacturer 15
BQ Plus Medical Co., Ltd. Songjiang Shanghai Contract manufacturer 13
Ningbo Great Mountain Medical Instruments Co., Ltd. Ningbo Zhejiang Contract manufacturer 12
Ambu Limited Xiang Yu F.T.Z., Xiamen Fujian Contract manufacturer 11
Xiantao Sanda Industrial Co., Ltd. Xiantao Hubei Contract manufacturer 10
Honsun (Nantong) Co., Ltd. Nantong Jiangsu Contract manufacturer 9

Showing 12 of 71. All 71 manufacturers in China registered for Mask, Gas, Anesthetic

Record

Regulatory record for ASP Medical
Listed by ASP Global, LLC, United States
FDA product code BSJ
Device type Mask, Gas, Anesthetic
Device class Class 1
Regulation 21 CFR 868.5550
Establishment Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
Premarket notification Exempt
Record published 2022-07-22
Record revised 2023-03-20 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Latex Contains natural rubber latex
Distribution end date 2023-03-17

Catalogue Numbers

Catalogue numbers for ASP Medical
Catalogue number Size Status
MAT111 In distribution
MAT112 In distribution
MAT114 In distribution
MAT113 In distribution
MAT116 In distribution
MAT110 Withdrawn
MAT115 Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Ventlab Ventlab, LLC 205
Medline Medline Industries, Inc. 49
Rusch Teleflex Medical LLC 45
Portex ICU Medical, Inc 33
Compower Xiamen Compower Medical Tech. Co., Ltd. 29
AincA® Anesthesia Associates, Inc. 29
Hudson RCI Teleflex Medical LLC 27
Deluxe Full Face Mask Mercury Medical Enterprises, LLC 27
King Mask Ambu A/S 26
Mask, Gas, Anesthetic VBM Medizintechnik Gmbh 23
Cardinal Health Cardinal Health 200, LLC 23
Vital Signs™ Airlife, Inc. 19

Showing 12 of 270. All products under Mask, Gas, Anesthetic

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