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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 Silicone Foam 4 x 4in. Dressing Partial to full thickness wounds: -Pressure ulcers -Traumatic wounds (eg. skin tears and secondary healing wounds) -Graft and donor sites -Post-operative surgical wounds -Diabetic, venous, and arterial ulcers Highly absorbent foam pad Gentle silicone adhesive Protective film backing Directions for use: 1. Clean wound with appropriate wound cleanser such as Cardinal Health Wound Cleanser. Dry surrounding skin thoroughly. 2. Remove dressing from packaging and if necessary cut dressing to size. For dressings smaller than 5x5 inches, there should be a 3/4-inch overlap onto the dry skin surrounding the wound. For dressings larger than 5x5 inches, there should be a 2-inch overlap. 3. Affix dressing over wound considering the overlap recommendations to protect the surrounding skin. 4. If necessary, cover this primary dressing with a moisture retentive secondary dressing to protect and promote a moist wound healing environment. 5. All dressings should be monitored frequently. Remove dressing when clinically indicated, such as leakage or increased pain, or after a maximum of 7 days. Not made with natural rubber latex Indications: May be used for the management of moderately exuding, partial to full thickness wounds, including: -Pressure ulcers -Traumatic wounds (eg. skin tears and secondary healing wounds) -Graft and donor sites -Post-operative surgical wounds -Diabetic, venous, and arterial ulcers FDA UDI
Model / Reference
FM44 FDA UDI
Description
Cardinal Health Silicone Foam 4 x 4in. Dressing Partial to full thickness wounds: -Pressure ulcers -Traumatic wounds (eg. skin tears and secondary healing wounds) -Graft and donor sites -Post-operative surgical wounds -Diabetic, venous, and arterial ulcers Highly absorbent foam pad Gentle silicone adhesive Protective film backing Directions for use: 1. Clean wound with appropriate wound cleanser such as Cardinal Health Wound Cleanser. Dry surrounding skin thoroughly. 2. Remove dressing from packaging and if necessary cut dressing to size. For dressings smaller than 5x5 inches, there should be a 3/4-inch overlap onto the dry skin surrounding the wound. For dressings larger than 5x5 inches, there should be a 2-inch overlap. 3. Affix dressing over wound considering the overlap recommendations to protect the surrounding skin. 4. If necessary, cover this primary dressing with a moisture retentive secondary dressing to protect and promote a moist wound healing environment. 5. All dressings should be monitored frequently. Remove dressing when clinically indicated, such as leakage or increased pain, or after a maximum of 7 days. Not made with natural rubber latex Indications: May be used for the management of moderately exuding, partial to full thickness wounds, including: -Pressure ulcers -Traumatic wounds (eg. skin tears and secondary healing wounds) -Graft and donor sites -Post-operative surgical wounds -Diabetic, venous, and arterial ulcers FDA UDI

Identifiers

Catalog Number
FM44 FDA UDI
Primary DI / UDI-DI
10885380065279 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 6c135837-697e-49d6-882c-b67e0fa04517 35 fields · synced Jun 8, 2026