Rusch

RUSCH Cushioned Disposable Face Mask With Valve Size 2 Pediatric

Registry build 21.09.26
71manufacturers in China registered for this device type
45catalogue 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 Rusch
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 2019-05-08
Record revised 2025-01-16 (version 4)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Single use Yes
Prescription Prescription only
Latex Labelled latex-free
Label carries lot or batch number, expiry date, manufacturing date
Storage Handling environment humidity 0 to 80 % RH; Handling environment temperature -5 to 40 °C; Storage environment temperature -5 to 40 °C
Packaging Case of 20, case of 30, box of 30, box of 500, case of 210, case of 100
Sizes Length 65 to 126 mm; width 60 to 108 mm; height 45 to 93 mm

Catalogue Numbers

Catalogue numbers for Rusch
Catalogue number Size Per pack Status
IPN049644 Length 89 mm In distribution
IPN929066 In distribution
IPN049451 In distribution
IPN049389 In distribution
IPN049450 In distribution
IPN039690 In distribution
IPN929062 In distribution
IPN045567 10 In distribution
IPN049640 Width 95 mm In distribution
IPN049639 Height 51 mm In distribution
IPN929065 In distribution
IPN929061 In distribution
IPN039688 In distribution
IPN039683 In distribution
IPN042560 No. 0 2 In distribution
IPN049642 Length 126 mm In distribution
IPN049446 In distribution
IPN929068 In distribution
IPN039691 In distribution
IPN039693 In distribution
IPN929071 In distribution
IPN929070 In distribution
IPN049641 Width 95 mm In distribution
IPN049445 In distribution
IPN049443 In distribution
IPN929069 In distribution
IPN929060 In distribution
IPN042562 No. 2 2 In distribution
IPN039692 In distribution
IPN929058 In distribution
IPN049977 10 In distribution
IPN929074 In distribution
IPN049449 In distribution
IPN929064 In distribution
IPN929073 In distribution
IPN042561 No. 1 2 In distribution
IPN929059 In distribution
IPN049643 Width 60 mm In distribution
IPN049444 In distribution
IPN929063 In distribution
IPN042563 No. 3 2 In distribution
IPN929072 In distribution
IPN049381 50 In distribution
IPN039689 In distribution
IPN049448 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
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
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