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

FDA UDI

Class I (US FDA UDI)

by Urocare Products, Inc.

Identity

Trade Name
Tracho-Foam® Double-Sided Adhesive Foam Disc, Standard 2.25" OD (Box of 30) FDA UDI
Generic Name
Tracheostomy tube dressing FDA UDI
Device Name
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). FDA UDI
Model / Reference
5300 FDA UDI
Description
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). FDA UDI

Identifiers

Catalog Number
5300 FDA UDI
Primary DI / UDI-DI
00792293053008 FDA UDI
FDA Product Code
EZR FDA UDI
NNX FDA UDI
KGX FDA UDI
GMDN Term
Tracheostomy tube dressing FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
876.5900 FDA UDI
876.5250 FDA UDI
880.5240 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size
Outer Diameter — 2.25 Inch FDA UDI
Lumen/Inner Diameter — 1.0 Inch FDA UDI
Height — 0.13 Inch FDA UDI
Weight — 0.002 Pound FDA UDI

Category: Tracheostomy tube speech valveSkin surface device adhesiveTracheostomy tube dressingIntestinal ostomy base plate, concave

Tracho-Foam® Double-Sided Adhesive Foam Disc, Standard 2.25" OD (Box of 30) by Urocare Products, Inc. — Class I — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Intestinal ostomy base plate, concave.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Urocare Products, Inc.

Sources (1)

  • FDA UDI 4f9b752e-8f22-4fcc-940b-7f0bade0f273 37 fields · synced May 30, 2026