CARDINAL HEALTH

Primary DI
10888499001084
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
FM820LTE
Catalog number
FM820LTE
Device description
Cardinal Health Silicone Foam Lite 8 x 20in. Dressing Partial 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 reactions Absorbent thin 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 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 reactions Can 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
Rx
false
OTC
true
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
NADDressing, wound, occlusive

Product Code Classifications

CodeDeviceSpecialtyClass
NADDressing, Wound, OcclusiveGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00888499001087PackageGS15In Commercial Distribution
10888499001084PackageGS15In Commercial Distribution
10885380065262PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00888499001087008884990010878884990010870888499001087
1088849900108410888499001084
1088538006526210885380065262

GMDN Terms

TermDefinition
Cavity-wound management dressingA 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 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

TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius35 Degrees Celsius

Sterilization Methods

Method

Regulatory Flags

DUNS number
961027315
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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