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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 Heel 4.7 x 7.5in. Dressing Partial to full thickness wounds: -Pressure ulcers -Traumatic wounds -Venous, arterial, and diabetic ulcers -First and second degree burns -Surgical incisions and excisions Highly absorbent foam pad Gentle silicone adhesive Protective film backing Designated to fit the heel 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 remove release liner. 3. Affix dressing under the foot and mold the dressing around the heel, bringing the edges together. There should be a 1-inch overlap onto the dry skin surrounding the wound. 4. Hold dressing securely in place and cover with light bandage or other dressing retention method, such as Cardinal Health Net Tube Gauze. Tape or film can be used to seal the joints on the sides of the dressing after application. 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 moderate to heavy exuding, partial to full thickness wounds on the heel, including: -Pressure ulcers -Traumatic wounds -Venous, arterial, and diabetic ulcers -First and second degree burns -Surgical incisions and excisions FDA UDI
Model / Reference
FMHEEL FDA UDI
Description
Cardinal Health Silicone Foam Heel 4.7 x 7.5in. Dressing Partial to full thickness wounds: -Pressure ulcers -Traumatic wounds -Venous, arterial, and diabetic ulcers -First and second degree burns -Surgical incisions and excisions Highly absorbent foam pad Gentle silicone adhesive Protective film backing Designated to fit the heel 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 remove release liner. 3. Affix dressing under the foot and mold the dressing around the heel, bringing the edges together. There should be a 1-inch overlap onto the dry skin surrounding the wound. 4. Hold dressing securely in place and cover with light bandage or other dressing retention method, such as Cardinal Health Net Tube Gauze. Tape or film can be used to seal the joints on the sides of the dressing after application. 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 moderate to heavy exuding, partial to full thickness wounds on the heel, including: -Pressure ulcers -Traumatic wounds -Venous, arterial, and diabetic ulcers -First and second degree burns -Surgical incisions and excisions FDA UDI

Identifiers

Catalog Number
FMHEEL FDA UDI
Primary DI / UDI-DI
10885380065316 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 8e251434-7810-48c5-86b9-192fcc129419 35 fields · synced Jun 8, 2026