CARDINAL HEALTH

Primary DI
10885380065248
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
FM44LTE
Catalog number
FM44LTE
Device description
Cardinal HealthSilicone Foam Lite4 x 4in. DressingPartial to full thickness wounds: -Pressure ulcers-Traumatic wounds-Venous, arterial and diabetic ulcers-Lacerations and abrasions-Finger injuries-Blisters-Partial thickness burns-Epidermolysis bullosa-Painful wounds-Radiation skin reactionsAbsorbent thin foam padGentle silicone adhesiveProtective film backingDirections 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 latexIndications: May be used for the management of dry to light exuding, partial to full thickness wounds, including:-Pressure ulcers-Traumatic wounds-Venous, arterial and diabetic ulcers-Lacerations and abrasions-Finger injuries-Blisters-Partial thickness burns-Epidermolysis bullosa-Painful wounds-Radiation skin reactionsCan also be used to provide protection of compromised and/or fragile skin.
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
00888499001063PackageGS110In Commercial Distribution
10888499001060PackageGS15In Commercial Distribution
10885380065248PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888499001063008884990010638884990010630888499001063
1088849900106010888499001060
1088538006524810885380065248

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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10192253072822Curity8442568442562026-10-08
10885380207150Curity4100A4100A2026-10-08
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50885380207202Curity41000410002026-10-08
50885380207219Curity4103A4103A2026-10-08
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50885380207233Curity4105A4105A2026-10-08
50885380207240Curity42000420002026-10-08
50885380207257Curity43000430002026-10-08

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