AincA®

Mask, Laryngeal Airway, UltraFlex EX, Size 5.0 (9.4mmID), 15mmM, 40xReusable-Reinforced, Silicone

Registry build 21.09.26
84manufacturers in China registered for this device type
21catalogue 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 AincA®
Listed by Anesthesia Associates, Inc., United States
FDA product code CAE
Device type Airway, Oropharyngeal, Anesthesiology
Device class Class 1
Regulation 21 CFR 868.5110
Establishment Contract manufacturer, Remanufacturer, Specification developer, Repacker / relabeller, Manufacturer
Premarket notification Exempt
Record published 2021-03-31

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
Sizes Length 9 to 10 cm
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for AincA®
Catalogue number Size Per pack Status
LF-380-60 6 In distribution
LF-380-50 5 In distribution
LF-390-50 5 In distribution
LF-390-30 3 In distribution
00-485 Length 9 cm 10 In distribution
LF-380-10 1 In distribution
LF-390-40 4 In distribution
LF-380-40 4 In distribution
LF-380-30 3 In distribution
00-492 Size 2, Small In distribution
LF-380-25 2.5 In distribution
LF-390-20 2 In distribution
LF-380-20 2 In distribution
00-494 Size 4, Large In distribution
00-486 Length 10 cm 10 In distribution
LF-390-60 6 In distribution
E-127 In distribution
LF-390-25 2.5 In distribution
LF-390-15 1.5 In distribution
LF-390-10 1 In distribution
LF-380-15 1.5 In distribution

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