Shiley

Laryngeal Mask

Registry build 21.09.26
84manufacturers in China registered for this device type
8catalogue numbers in this listing

Who Else Makes It

Concentrated in Zhejiang (30), Guangdong (18), Jiangsu (12). 20 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code CAE
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
Gcmedica Enterprise Ltd.(Wuxi) Wuxi Jiangsu Contract manufacturer 55
Flexicare Medical (Dongguan) Ltd. Dongguan Guangdong Contract manufacturer 48
Hangzhou Fushan Medical Appliance Co., Ltd. Hangzhou Zhejiang Contract manufacturer 44
GaleMed (Xiamen) Co., Ltd. Xiamen Fujian Contract manufacturer 33
Ningbo Luke Medical Devices Co., Ltd. Yuyao Zhejiang Contract manufacturer 27
Zhejiang Haisheng Medical Device Co., Ltd. Shaoxing Zhejiang Contract manufacturer 21
Tylenol Medical Instruments Co., Ltd. Zhongshan Guangdong Contract manufacturer 15
IPE Plastic & Hardware Industy, Ltd Dongguan Guangdong Contract manufacturer 15
Forefront Medical Technology (Jiangsu) Co., Ltd. Changzhou Jiangsu Contract manufacturer 14
Ningbo Great Mountain Medical Instruments Co., Ltd. Ningbo Zhejiang Contract manufacturer 12

Showing 12 of 84. All 84 manufacturers in China registered for Airway, Oropharyngeal, Anesthesiology

Record

Regulatory record for Shiley
Listed by Covidien LP, United States
FDA product code CAE
Device type Airway, Oropharyngeal, Anesthesiology
Device class Class 1
Regulation 21 CFR 868.5110
Premarket notification Exempt
Record published 2018-09-20
Record revised 2025-06-24 (version 9)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Label carries lot or batch number, expiry date
Storage Special storage condition: Keep Dry;AVOID DIRECT SUNLIGHT
Packaging Pack_or_inner_pack of 10, case of 5
Sizes Total volume 4 to 50 ml
Distribution end date 2025-03-07

Catalogue Numbers

Catalogue numbers for Shiley
Catalogue number Size Status
33760 Total Volume 50 ml In distribution
33730 Size 3, 30-50, kg; Pressure, 60, cmH2O; Inside Diameter, 10.0, mm; In distribution
33715 Total Volume 7 ml In distribution
33720 Total Volume 10 ml In distribution
33725 Total Volume 14 ml In distribution
33740 Size 4, 50-70 kg; Pressure, 60, cmH2O; Inside Diameter, 10.0, mm; In distribution
33710 Size 1, < 5, kg; Pressure, 60, cmH2O; Inside Diameter, 6.0, mm; In distribution
33750 Total Volume 40 ml Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
LMA Airway Management Teleflex Medical LLC 444
Rusch Teleflex Medical LLC 129
SourceMark Sourcemark, LLC. 94
Curaplex Bound Tree Medical, LLC 86
Hudson RCI Teleflex Medical LLC 83
SunMed SunMed Group Holdings, LLC 66
Medline Medline Industries, Inc. 59
LMA Teleflex Medical LLC 50
MediChoice Owens & Minor Distribution, Inc. 33
ADC® American Diagnostic Corp. 32
Air-Q3® Airlife, Inc. 32
Compower Xiamen Compower Medical Tech. Co., Ltd. 29

Showing 12 of 347. All products under Airway, Oropharyngeal, Anesthesiology

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