Hudson RCI

Hudson RCI Clear Comfort AIR Cushion Face Mask Medium Adult

Registry build 21.09.26
71manufacturers in China registered for this device type
27catalogue 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 Hudson RCI
Listed by Teleflex Medical LLC, United States
FDA product code BSJ
Device type Mask, Gas, Anesthetic
Device class Class 1
Regulation 21 CFR 868.5550
Establishment Specification developer, Complaint-file establishment, Manufacturer
Premarket notification Exempt
Record published 2019-06-18
Record revised 2025-09-09 (version 4)

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, expiry date, manufacturing date
Storage Special storage condition: UNSPECIFIED
Packaging Case of 20, case of 30
Sizes Width 60 to 108 mm; height 45 to 93 mm; length 65 to 126 mm

Catalogue Numbers

Catalogue numbers for Hudson RCI
Catalogue number Size Status
IPN049613 No clinically relevant sizes currently defined In distribution
IPN049622 No clinically relevant sizes currently defined In distribution
IPN049610 Width 95 mm In distribution
IPN039677 In distribution
IPN039680 In distribution
IPN049607 Length 75 mm In distribution
IPN039678 In distribution
IPN049617 No clinically relevant sizes currently defined In distribution
IPN049619 No clinically relevant sizes currently defined In distribution
IPN049612 No clinically relevant sizes currently defined In distribution
IPN049614 No clinically relevant sizes currently defined In distribution
IPN049620 No clinically relevant sizes currently defined In distribution
IPN049609 Height 79 mm In distribution
IPN039697 In distribution
IPN039681 In distribution
IPN049618 No clinically relevant sizes currently defined In distribution
IPN049611 Height 93 mm In distribution
IPN039695 In distribution
IPN039694 In distribution
IPN049615 No clinically relevant sizes currently defined In distribution
IPN049606 Height 45 mm In distribution
IPN049621 No clinically relevant sizes currently defined In distribution
IPN049616 No clinically relevant sizes currently defined In distribution
IPN039676 In distribution
IPN049608 Width 82 mm In distribution
IPN049623 No clinically relevant sizes currently defined In distribution
IPN039698 In distribution

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
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
Exin Foremount Enterprise Co., Ltd. 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