Trach Tie

Pedi / Neo Trach Tube Holder

Registry build 21.09.26
46manufacturers in China registered for this device type
27catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (12), Zhejiang (12), Guangdong (9). 16 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code CBH
Manufacturer City Province Registered as Device types
Flexicare Medical (Dongguan) Ltd. Dongguan Guangdong Contract manufacturer 48
Principle & Will Biotech (Pinghu) Co., Ltd. Pinghu Zhejiang Contract manufacturer 39
Dongguan Shin YI Healthcare Products Factory Dong Guan Guangdong Contract manufacturer 30
Jiangsu Huadong Medical Device Industry Co., Ltd. Yangzhou Jiangsu Contract manufacturer 29
Jingmen Huasheng Asia Dynamics Sanitary Products Co., Ltd. Jingmen Hubei Contract manufacturer 23
Yiwu Haoding Medical Co., Ltd. Yiwu Zhejiang Contract manufacturer 23
Zhejiang Haisheng Medical Device Co., Ltd. Shaoxing Zhejiang Contract manufacturer 21
Huizhou Foryou Medical Devices Co., Ltd. Huizhou Guangdong Contract manufacturer 18
Xiantao Rayxin Medical Products Co., Ltd. Xiantao Hubei Contract manufacturer 18
Hitec Medical Co., Ltd. Shanghai Shanghai Contract manufacturer 17
VR Medical Technology Co., Ltd. Kunshan Jiangsu Contract manufacturer 13
Ningbo Great Mountain Medical Instruments Co., Ltd. Ningbo Zhejiang Contract manufacturer 12

Showing 12 of 46. All 46 manufacturers in China registered for Device, Fixation, Tracheal Tube

Record

Regulatory record for Trach Tie
Listed by Pepper Medical, Inc., United States
FDA product code CBH
Device type Device, Fixation, Tracheal Tube
Device class Class 1
Regulation 21 CFR 868.5770
Establishment Specification developer, Repacker / relabeller, Manufacturer
Premarket notification Exempt
Record published 2020-04-17
Record revised 2024-08-02 (version 4)

Specifications

Specifications
MRI safety MR Safe
Single use Yes
Over the counter Yes
Latex Labelled latex-free
Label carries lot or batch number, manufacturing date
Packaging Box of 10, box of 20, pack of 10

Catalogue Numbers

Catalogue numbers for Trach Tie
Catalogue number Size Per pack Status
597S 10 In distribution
542 In distribution
1001 In distribution
301-Beige 20 In distribution
503 10 In distribution
300 20 In distribution
501 In distribution
302L 10 In distribution
540 10 In distribution
541 10 In distribution
502 In distribution
502P In distribution
504T 10 In distribution
504 10 In distribution
V542 20 In distribution
V501 20 In distribution
701VCS 5 In distribution
302M 10 In distribution
501W In distribution
V301 20 In distribution
301 In distribution
597L 10 In distribution
444 50 In distribution
540W 10 In distribution
V540 20 In distribution
597M 10 In distribution
302S 10 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
EZCare™ Softouch Neotech Products, LLC 31
Marpac Inc Marpac, Inc. 29
Tracoe care Tracoe Medical Gmbh 15
Dr Zee Resp Devices LLC 14
NeoBar® Neotech Products, LLC 14
Bioseal Inc. Bioseal 14
ProCure Twin Med, LLC 13
Hudson RCI Teleflex Medical LLC 11
Vent Tie Pepper Medical, Inc. 10
Medline Medline Industries, Inc. 9
Posey Posey Products, LLC 8
McKesson Mckesson Medical-Surgical Inc. 7

Showing 12 of 123. All products under Device, Fixation, Tracheal Tube

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