Duns Number:961027315
Device Description: Cardinal HealthNon-Adhesive Foam Tracheostomy3.5 x 3.5in. DressingManagement of fluid, sec Cardinal HealthNon-Adhesive Foam Tracheostomy3.5 x 3.5in. DressingManagement of fluid, secretion, or exudate build-up for the peristomal area created by: -Tracheostomy tubes-Other drains and tubesHighly absorbent foam badProtective film backingNon-adherent, fenestrated shapeDirections for use: 1. Clean wound area with appropriate wound cleanser such as Cardinal Health Wound Cleanser. Prepare and clean the skin surrounding the tracheostomy tube by removing excess moisture.2. Remove dressing from packaging and fit dressing around the stoma or tracheostomy tube. Apply the white side towards the patient's skin. Dressing may be cut to shape for a better fit.3. Additional fixation such as Cardinal Health Transparent Film or Tape may be used to secure the dressing.4. All dressings should be monitored frequently. Dressings can be left in place for up to 7 days, or until visible drainage is 3/4 inch from the edge of the dressing. Remove dressing when clinically indicated, such as leakage or increased pain.Not made with natural rubber latexIndicationsManagement of fluid, secretion or exudate build-up for the peristomal area created by: -Tracheostomy tubes-Other drains and tubes
Catalog Number
FMTRACH
Brand Name
CARDINAL HEALTH
Version/Model Number
FMTRACH
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
779d0bdc-997c-466c-9944-37fcc4bba194
Public Version Date
June 19, 2020
Public Version Number
3
DI Record Publish Date
May 30, 2019
Package DI Number
10888499001145
Quantity per Package
5
Contains DI Package
00888499001148
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| 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 |