Respiratory Accessory

Standard CSS, Neo/Pediatric, 405mm, 10Fr, Y-Adapter (4.5-5.5mm), MDI, sterile, latex-free

Registry build 21.09.26
58manufacturers in China registered for this device type
5catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (19), Guangdong (14), Zhejiang (9). 15 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code GCY
Manufacturer City Province Registered as Device types
Hangzhou Rollmed Co., Ltd. Hangzhou Zhejiang Contract manufacturer 127
Firstar Healthcare Company Limited (Guangzhou) Guangzhou Guangdong Contract manufacturer 57
Jiangsu JianYu Health Medical Co., Ltd. Changzhou Jiangsu Contract manufacturer 35
Conod Medical Shuyang Co., Ltd. Shuyang Jiangsu Contract manufacturer 22
Shun SZE Industrial (Shenzhen) Co., Ltd. Shenzhen Guangdong Contract manufacturer 22
Primecare Medical (Suzhou) Co., Ltd. Changshu Jiangsu Contract manufacturer 20
iBrite Suzhou Technology Co., Ltd. Suzhou Jiangsu Contract manufacturer 18
Ningbo Albert Novosino Co., Ltd. Yuyao Zhejiang Contract manufacturer 17
Zibo Dante Co., Ltd. Zibo Shandong Contract manufacturer 17
Beilun Plastech Inc Ningbo Zhejiang Contract manufacturer 13
Changshu Beyond Medical Device Co., Ltd. Changshu Jiangsu Contract manufacturer 9
Fansheng Technology (Guangdong) Co., Ltd. Zhongshan Guangdong Contract manufacturer 8

Showing 12 of 58. All 58 manufacturers in China registered for Apparatus, Suction, Single Patient Use, Portable, Nonpowered

Record

Regulatory record for Respiratory Accessory
Listed by Sunset Healthcare Solutions, Inc., United States
FDA product code GCY
Device type Apparatus, Suction, Single Patient Use, Portable, Nonpowered
Device class Class 1
Regulation 21 CFR 878.4680
Establishment Contract manufacturer, Repacker / relabeller, Complaint-file establishment, Manufacturer
Premarket notification Exempt
Record published 2024-08-05

Specifications

Specifications
MRI safety MR Unsafe
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Latex Labelled latex-free
Label carries lot or batch number, expiry date, manufacturing date

Catalogue Numbers

Catalogue numbers for Respiratory Accessory
Catalogue number Size Per pack Status
VEN66000500M 20 In distribution
VEN66000700M 20 In distribution
VEN66001000M 20 In distribution
VEN66000700 20 In distribution
VEN66001000 20 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Bioseal Inc. Bioseal 169
Cardinal Health Cardinal Health 200, LLC 50
Closed Suction Sunset Healthcare Solutions, Inc. 49
Closed Wound Suction C.R. Bard, Inc. 37
Barovac® Evacuator Closed Wound Drainage System(SS) Sewoon Medical Co., Ltd. 33
Hemovac® Wound Drainage System Zimmer Orthopaedic Surgical Products 23
Barovac® Evacuator Closed Wound Drainage System(PP) Sewoon Medical Co., Ltd. 22
Deluxe Closed Suction System 72hr Sunset Healthcare Solutions, Inc. 20
Tru-Close Suction Drainage System Uresil, LLC 19
Deluxe Closed Suction System Sunset Healthcare Solutions, Inc. 19
Tracheostomy and Suction Accessory Sunset Healthcare Solutions, Inc. 18
S-Vac® Fluted Channel Drain Aspen Surgical Products, Inc. 17

Showing 12 of 110. All products under Apparatus, Suction, Single Patient Use, Portable, Nonpowered

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