Provox Tracheofix

Provox Tracheofix is a single-use foam protector intended to absorb secretions and to provide protection and aesthetic coverage of the tracheostoma.

Registry build 21.09.26
195manufacturers in China registered for this device type
7catalogue numbers in this listing

Who Else Makes It

Concentrated in Zhejiang (55), Jiangsu (42), Guangdong (32). 33 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code NAC
Manufacturer City Province Registered as Device types
Shanghai Joy Crown Industry Co., Ltd. Pu Dong New Area Shanghai Contract manufacturer 64
Hubei V-Medical Products Co., Ltd. Xiantao Hubei Contract manufacturer 46
Allmed Medical Products Co., Ltd. Zhijiang Hubei Contract manufacturer 43
Shanghai Care Us Medical Product Co., Ltd. Shanghai Shanghai Contract manufacturer 30
Planet (Anhui) Medical Products Co., Ltd. Chuzhou Anhui Contract manufacturer 30
Jinhua Jingdi Medical Supplies Co., Ltd. Jinhua Zhejiang Contract manufacturer 29
Weihai Kangzheng Medical Equipments Technology Co., Ltd. Weihai Shandong Contract manufacturer 26
Nanjing 3H Medical Products Co., Ltd. Nanjing Jiangsu Contract manufacturer 25
Yiwu Haoding Medical Co., Ltd. Yiwu Zhejiang Contract manufacturer 23
Changzhou Recoo Healthcare Co., Ltd. Changzhou Jiangsu Contract manufacturer 19
Henso Medical (Hangzhou) Co., Ltd. Hangzhou Zhejiang Contract manufacturer 19
Huizhou Foryou Medical Devices Co., Ltd. Huizhou Guangdong Contract manufacturer 18

Showing 12 of 195. All 195 manufacturers in China registered for Dressing, Wound, Hydrophilic

Record

Regulatory record for Provox Tracheofix
Listed by Atos Medical AB, Sweden
FDA product code NAC
Device type Dressing, Wound, Hydrophilic
Device class Class 1
Regulation 21 CFR 878.4018
Establishment Manufacturer
Premarket notification Exempt
Record published 2022-07-11
Record revised 2024-10-03 (version 3)

Specifications

Specifications
MRI safety MR Safe
Single use Yes
Over the counter Yes
Label carries lot or batch number, expiry date, manufacturing date
Storage Special storage condition: Keep dry. Keep away from sunlight.; Storage environment temperature 2 to 42 °C; Storage environment temperature 36 to 108 °F
Sizes Height 38 to 70 mm; width 60 to 70 mm
Distribution end date 2024-10-02

Catalogue Numbers

Catalogue numbers for Provox Tracheofix
Catalogue number Size Per pack Status
1 strip beige 38×63 Height 38 mm 10 Withdrawn
2 strips beige 55×60 Height 55 mm 10 Withdrawn
1 strip beige 70×70 Height 70 mm 10 Withdrawn
1 strip ivory 70×70 Height 70 mm 10 Withdrawn
1 strip beige 55×60 Height 55 mm 10 Withdrawn
2 strip ivory 70×70 Height 70 mm 10 Withdrawn
1 strip ivory 55×60 Height 55 mm 10 Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
DeRoyal Deroyal Industries, Inc. 170
Simpurity Safe N Simple LLC 91
AMD-Ritmed ALL Gauze AMD Medicom Inc. 80
3M™ Tegaderm™ 3M Company 78
Cutimed® Sorbion® BSN Medical, Inc. 70
AMD-Ritmed AMD Medicom Inc. 63
Medline Medline Industries, Inc. 56
Dododots Dodo Ventures SDN. BHD 42
Aquacel Foam Convatec, Purchasing Department 39
McKesson Mckesson Medical-Surgical Inc. 37
Vitale CellEra, LLC 36
MedVance MED WAY Inc. 36

Showing 12 of 432. All products under Dressing, Wound, Hydrophilic

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