Duns Number:961027315
Device Description: Cardinal HealthSilicone Foam Heel4.7 x 7.5in. DressingPartial to full thickness wounds: -P 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
Catalog Number
FMHEEL
Brand Name
CARDINAL HEALTH
Version/Model Number
FMHEEL
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
8e251434-7810-48c5-86b9-192fcc129419
Public Version Date
June 19, 2020
Public Version Number
3
DI Record Publish Date
May 30, 2019
Package DI Number
00888499001131
Quantity per Package
5
Contains DI Package
10885380065316
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 |