CARDINAL HEALTH
Basic Information
- Brand Name
- CARDINAL HEALTH
- Primary DI
- 10885380065286
- Version / Model
- FM48
- Catalog Number
- FM48
- 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
- 66389649-5ec6-4e95-b23f-bd0c91c27e76
Device Description
Cardinal Health Silicone Foam 4 x 8in. Dressing Partial 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 ulcers Highly absorbent foam pad Gentle silicone adhesive Protective film backing Directions 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 latex Indications: 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
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 | 10888499001107 | GS1 | CASE | 5 | In Commercial Distribution | |
| Package | 00888499001100 | GS1 | BOX | 10 | In Commercial Distribution | |
| Primary | 10885380065286 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – 35 Degrees Celsius