CARDINAL HEALTH - Cardinal HealthSilicone Foam Lite8 x 20in. - Cardinal Health 200, LLC

Duns Number:961027315

Device Description: Cardinal HealthSilicone Foam Lite8 x 20in. DressingPartial to full thickness wounds: -Pres Cardinal HealthSilicone Foam Lite8 x 20in. 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.

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More Product Details

Catalog Number

FM820LTE

Brand Name

CARDINAL HEALTH

Version/Model Number

FM820LTE

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

NAD

Product Code Name

Dressing, wound, occlusive

Device Record Status

Public Device Record Key

b87f73b4-4e6f-44cc-b8bd-7700b42cf1ee

Public Version Date

June 19, 2020

Public Version Number

3

DI Record Publish Date

May 30, 2019

Additional Identifiers

Package DI Number

10888499001084

Quantity per Package

5

Contains DI Package

00888499001087

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE

"CARDINAL HEALTH 200, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 101686
2 A medical device with a moderate to high risk that requires special controls. 139430
3 A medical device with high risk that requires premarket approval 8
U Unclassified 40