EZCare™ Softouch

The EZCare Softouch is intended to secure a patient’s tracheostomy tube. It is intended for use on pediatric (neonates, infants and children) patients.

Registry build 21.09.26
46manufacturers in China registered for this device type
31catalogue 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 EZCare™ Softouch
Listed by Neotech Products, LLC, 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, Complaint-file establishment, Manufacturer
Premarket notification Exempt
Record published 2021-06-14
Record revised 2023-09-19 (version 7)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Prescription Prescription only
Over the counter Yes
Latex Contains natural rubber latex
Label carries lot or batch number, expiry date, manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for EZCare™ Softouch
Catalogue number Size Per pack Status
5″ Pink 20 In distribution
Large – Black 20 In distribution
9″ Pink 20 In distribution
5″ Camouflage 20 In distribution
11″ Camouflage 20 In distribution
6″ Tan 20 In distribution
8″ Tan 20 In distribution
10″ Black 20 In distribution
5″ Tan 20 In distribution
8″ Camouflage 20 In distribution
10″ Pink 20 In distribution
Medium Tan 20 In distribution
8″ Blue 20 In distribution
8″ Pink 20 In distribution
9″ Tan 20 In distribution
10″ Tan 20 In distribution
7″ Pink 20 In distribution
9″ Camouflage 20 In distribution
6″ Pink 20 In distribution
10″ Camouflage 20 In distribution
6″ Camouflage 20 In distribution
11″ Blue 20 In distribution
6″ Blue 20 In distribution
11″ Tan 20 In distribution
5″ Blue 20 In distribution
11″ Pink 20 In distribution
7″ Camouflage 20 In distribution
7″ Tan 20 In distribution
7″ Blue 20 In distribution
9″ Blue 20 In distribution
10″ Blue 20 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Marpac Inc Marpac, Inc. 29
Trach Tie Pepper Medical, Inc. 27
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