CARDINAL HEALTH
Basic Information
- Brand Name
- CARDINAL HEALTH
- Primary DI
- 10885380065323
- Version / Model
- FMTRACH
- Catalog Number
- FMTRACH
- Company Name
- Cardinal Health 200, LLC
- Labeler DUNS
- 961027315
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-05-30
- Public Version
- 3
- Public Version Date
- 2020-06-19
- Public Version Status
- Update
- Public Device Record Key
- 779d0bdc-997c-466c-9944-37fcc4bba194
Device Description
Cardinal Health Non-Adhesive Foam Tracheostomy 3.5 x 3.5in. Dressing Management of fluid, secretion, or exudate build-up for the peristomal area created by: -Tracheostomy tubes -Other drains and tubes Highly absorbent foam bad Protective film backing Non-adherent, fenestrated shape Directions 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 latex Indications Management of fluid, secretion or exudate build-up for the peristomal area created by: -Tracheostomy tubes -Other drains and tubes
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NAD | Dressing, wound, occlusive | General, Plastic Surgery | 878.4020 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36226 | Cavity-wound management dressing, non-antimicrobial | A 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 does not include an antimicrobial agent(s). 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10888499001145 | GS1 | CASE | 5 | In Commercial Distribution | |
| Package | 00888499001148 | GS1 | BOX | 5 | In Commercial Distribution | |
| Primary | 10885380065323 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – 35 Degrees Celsius