Tracho-Foam® Double-Sided Adhesive Foam Disc, Standard 2.25″ OD (Box of 30)

DISC, WAFER, DRESSING, ADHESIVE, FOAM, OSTOMY, STOMA, TRACHEOSTOMY, VOICE RESTORATION, SPEECH, VALVE Tracho-Foam® adhesive foam discs are soft, pliable foam discs specifically designed for…

Registry build 21.09.26

DISC, WAFER, DRESSING, ADHESIVE, FOAM, OSTOMY, STOMA, TRACHEOSTOMY, VOICE RESTORATION, SPEECH, VALVE Tracho-Foam® adhesive foam discs are soft, pliable foam discs specifically designed for the unique bonding applications of appliances to the skin and are suitable for securing valve housings of voice restoration systems to the body. With adhesive coated on both sides, they provide a comfortable, air-tight seal that conforms to the irregular contours of the stoma and eliminate hissing a side effect often found in other thinner or less flexible products. Key Features: • Ensolite Foam → Hypo-Allergenic • Closed-Cell Foam Structure → for an air-tight seal that eliminates hissing. • Soft and Pliable → Easily conforms to irregular contours of the body. • Perspiration resistant → It retains it’s adhesive qualities even when sweating. • Easy to apply and Remove → Just peel ‘n’ Stick to apply, peel back to remove. If the disc is difficult to remove, Urocare® Adhesive Remover Pads may be used to soften the adhesive and assist in the removal of the disc. They contain a non-toxic, citrus-based adhesive remover that may also be used to remove most types of medical adhesive or adhesive residue from skin and appliances or in preparation for use of a new disc. Most medical grade adhesive removers will work basically in the same manner; however, consult your doctor or speech therapist to decide the best product for you and how to use it safely. For more information → see Urocare® Adhesive Remover Pads (#5600). In the event of skin that has become sensitive to aggressive medical adhesives, Urocare® has developed Uro-Prep® a protective skin barrier wipe for used under all types of medical adhesives. They protect delicate, sensitive skin from aggressive adhesives often used in conjunction with urinary or ostomy appliances. Uro-Prep® wipes are safe, effective, and for external use only. For more information → see Uro-Prep® (#5500).

7manufacturers in China registered for this device type
1catalogue number

Who Else Makes It

Concentrated in Zhejiang (4), Jiangsu (1), Hunan (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code EZR
Manufacturer City Province Registered as Device types
Zhende Medical Co., Ltd. Shaoxing Zhejiang Contract manufacturer 14
Shaoxing Haoshide Medical Products Co., Ltd. Shaoxing Zhejiang Contract manufacturer 7
Boen Healthcare Co., Ltd. Suzhou Jiangsu Specification developer 263
Hangzhou Rollmed Co., Ltd. Hangzhou Zhejiang Contract manufacturer 127
Cofoe Medical Technology Co., Ltd. Changsha Hunan Contract manufacturer 22
Hubei Hendry Medical Appliance Co., Ltd. Xiaogan Hubei Manufacturer 12
Tongxiang BAO-Health Medical Instrument Co., Ltd. Tongxiang Zhejiang Manufacturer 10

Record

Regulatory record for Tracho-Foam® Double-Sided Adhesive Foam Disc, Standard 2.25″ OD (Box of 30)
Listed by Urocare Products, Inc., United States
FDA product code EZR
Device type Cement, Stomal Appliance, Ostomy
Device class Class 1
Regulation 21 CFR 876.5900
Establishment Contract manufacturer, Repacker / relabeller, Manufacturer
Premarket notification Exempt
Record published 2018-06-01
Record revised 2022-11-09 (version 5)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Over the counter Yes
Latex Labelled latex-free
Label carries lot or batch number, expiry date, manufacturing date
Storage Special storage condition: Store in cool, dark, dry place.
Sizes Outer diameter 2.25 in; lumen/inner diameter 1 in; height 0.13 in; weight 0.002 lb
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Tracho-Foam® Double-Sided Adhesive Foam Disc, Standard 2.25″ OD (Box of 30)
Catalogue number Size Status
5300 Outer Diameter 2.25 in In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
McKesson Mckesson Medical-Surgical Inc. 6
cofoe Cofoe Medical Technology Co., Ltd. 5
Adapt Hollister Incorporated 2
Bynex Shaoxing Haoshide Medical Products Co., Ltd. 2
SecuriT Hollister Incorporated 2
Karaya 5 Hollister Incorporated 1

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