Duns Number:961027315
Device Description: Cardinal HealthSilicone Foam4 x 4in. DressingPartial to full thickness wounds: -Pressure u Cardinal HealthSilicone Foam4 x 4in. DressingPartial to full thickness wounds: -Pressure ulcers-Traumatic wounds (eg. skin tears and secondary healing wounds)-Graft and donor sites-Post-operative surgical wounds-Diabetic, venous, and arterial ulcersHighly absorbent 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 moderately exuding, partial to full thickness wounds, including:-Pressure ulcers-Traumatic wounds (eg. skin tears and secondary healing wounds)-Graft and donor sites-Post-operative surgical wounds-Diabetic, venous, and arterial ulcers
Catalog Number
FM44
Brand Name
CARDINAL HEALTH
Version/Model Number
FM44
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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
NAD
Product Code Name
Dressing, wound, occlusive
Public Device Record Key
6c135837-697e-49d6-882c-b67e0fa04517
Public Version Date
June 19, 2020
Public Version Number
3
DI Record Publish Date
May 30, 2019
Package DI Number
00888499001094
Quantity per Package
10
Contains DI Package
10885380065279
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
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 |