CARDINAL HEALTH

Primary DI
10885380065316
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
FMHEEL
Catalog number
FMHEEL
Device description
Cardinal HealthSilicone Foam Heel4.7 x 7.5in. DressingPartial to full thickness wounds: -Pressure ulcers-Traumatic wounds-Venous, arterial, and diabetic ulcers-First and second degree burns-Surgical incisions and excisionsHighly absorbent foam padGentle silicone adhesiveProtective film backingDesignated to fit the heelDirections 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 latexIndications: 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
Published
2019-05-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
NADDressing, wound, occlusive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NADDressing, Wound, OcclusiveGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888499001131PackageGS15In Commercial Distribution
10888499001138PackageGS15In Commercial Distribution
10885380065316PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888499001131008884990011318884990011310888499001131
1088849900113810888499001138
1088538006531610885380065316

GMDN Terms#

Term, Definition table
TermDefinition
Cavity-wound management dressing, non-antimicrobialA non-bioabsorbable material or substance designed to be inserted into a wound bed to create an appropriate environment for healing (e.g., warm, moist, absorbent); it does not include an antimicrobial agent(s). It is typically used for the management of deep secondary-healing wounds, particularly for indications such as stage III and IV pressure ulcers, deep leg ulcers, cavity wounds, excisions, and post-op wound dehiscence. It is often designed to conform to the wound bed to support tissues and is often nonadherent to provide for patient comfort during wound management. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius35 Degrees Celsius

Regulatory Flags#

DUNS number
961027315
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

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