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Cardinal Health

FDA UDI

Class I (US FDA UDI)

by Cardinal Health 200, LLC

Identity

Trade Name
CARDINAL HEALTH FDA UDI
Generic Name
Cavity-wound management dressing, non-antimicrobial FDA UDI
Device Name
Cardinal Health Non-Adhesive Foam Tracheostomy 3.5 x 3.5in. Dressing Management of fluid, secretion, or exudate build-up for the peristomal area created by: -Tracheostomy tubes -Other drains and tubes Highly absorbent foam bad Protective film backing Non-adherent, fenestrated shape Directions for use: 1. Clean wound area with appropriate wound cleanser such as Cardinal Health Wound Cleanser. Prepare and clean the skin surrounding the tracheostomy tube by removing excess moisture. 2. Remove dressing from packaging and fit dressing around the stoma or tracheostomy tube. Apply the white side towards the patient's skin. Dressing may be cut to shape for a better fit. 3. Additional fixation such as Cardinal Health Transparent Film or Tape may be used to secure the dressing. 4. All dressings should be monitored frequently. Dressings can be left in place for up to 7 days, or until visible drainage is 3/4 inch from the edge of the dressing. Remove dressing when clinically indicated, such as leakage or increased pain. Not made with natural rubber latex Indications Management of fluid, secretion or exudate build-up for the peristomal area created by: -Tracheostomy tubes -Other drains and tubes FDA UDI
Model / Reference
FMTRACH FDA UDI
Description
Cardinal Health Non-Adhesive Foam Tracheostomy 3.5 x 3.5in. Dressing Management of fluid, secretion, or exudate build-up for the peristomal area created by: -Tracheostomy tubes -Other drains and tubes Highly absorbent foam bad Protective film backing Non-adherent, fenestrated shape Directions for use: 1. Clean wound area with appropriate wound cleanser such as Cardinal Health Wound Cleanser. Prepare and clean the skin surrounding the tracheostomy tube by removing excess moisture. 2. Remove dressing from packaging and fit dressing around the stoma or tracheostomy tube. Apply the white side towards the patient's skin. Dressing may be cut to shape for a better fit. 3. Additional fixation such as Cardinal Health Transparent Film or Tape may be used to secure the dressing. 4. All dressings should be monitored frequently. Dressings can be left in place for up to 7 days, or until visible drainage is 3/4 inch from the edge of the dressing. Remove dressing when clinically indicated, such as leakage or increased pain. Not made with natural rubber latex Indications Management of fluid, secretion or exudate build-up for the peristomal area created by: -Tracheostomy tubes -Other drains and tubes FDA UDI

Identifiers

Catalog Number
FMTRACH FDA UDI
Primary DI / UDI-DI
10885380065323 FDA UDI
FDA Product Code
NAD FDA UDI
GMDN Term
Cavity-wound management dressing, non-antimicrobial FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4020 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

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

No

FDA UDI

Category: Cavity-wound management dressing, non-antimicrobial

Cardinal Health by Cardinal Health 200, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cavity-wound management dressing, non-antimicrobial.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Cardinal Health 200, LLC

Sources (1)

  • FDA UDI 779d0bdc-997c-466c-9944-37fcc4bba194 35 fields · synced Jun 8, 2026