CARDINAL HEALTH
- Primary DI
- 10888499001084
- Brand
- CARDINAL HEALTH
- Company
- Cardinal Health 200, LLC
- Model
- FM820LTE
- Catalog number
- FM820LTE
- Device description
- Cardinal Health Silicone Foam Lite 8 x 20in. Dressing Partial to full thickness wounds: -Pressure ulcers -Traumatic wounds -Venous, arterial and diabetic ulcers -Lacerations and abrasions -Finger injuries -Blisters -Partial thickness burns -Epidermolysis bullosa -Painful wounds -Radiation skin reactions Absorbent thin 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 dry to light exuding, partial to full thickness wounds, including: -Pressure ulcers -Traumatic wounds -Venous, arterial and diabetic ulcers -Lacerations and abrasions -Finger injuries -Blisters -Partial thickness burns -Epidermolysis bullosa -Painful wounds -Radiation skin reactions Can also be used to provide protection of compromised and/or fragile skin.
- Published
- 2019-05-30
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- true
- Sterile
- true
- Single use
- true
Product Codes
| Code | Name |
|---|
| NAD | Dressing, wound, occlusive |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| NAD | Dressing, Wound, Occlusive | General, Plastic Surgery | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00888499001087 | Package | GS1 | 5 | In Commercial Distribution |
| 10888499001084 | Package | GS1 | 5 | In Commercial Distribution |
| 10885380065262 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00888499001087 | 00888499001087 | 888499001087 | 0888499001087 |
| 10888499001084 | 10888499001084 | | |
| 10885380065262 | 10885380065262 | | |
GMDN Terms
| Term | Definition |
|---|
| Cavity-wound management dressing | 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 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. |
Storage And Handling
| Type | Low | High | Condition |
|---|
| Storage Environment Temperature | 0 Degrees Celsius | 35 Degrees Celsius | |
Regulatory Flags
- DUNS number
- 961027315
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company
Other Devices Sharing Product Codes
| Primary DI | Brand | Company | Product code | Published |
|---|
| 00612479282179 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | NAD | 2026-03-17 |
| 06974795053920 | MEDLOT | Henan Maidingkang Medical Technology Co., Ltd. | NAD | 2026-03-13 |
| 30885632495469 | Halyard | OWENS & MINOR DISTRIBUTION, INC. | NAD | 2026-03-13 |
| 20885632495851 | Halyard | OWENS & MINOR DISTRIBUTION, INC. | NAD | 2026-03-13 |
| 20885632495868 | Halyard | OWENS & MINOR DISTRIBUTION, INC. | NAD | 2026-03-13 |
| 20885632495875 | Halyard | OWENS & MINOR DISTRIBUTION, INC. | NAD | 2026-03-13 |
| 20885632495882 | Halyard | OWENS & MINOR DISTRIBUTION, INC. | NAD | 2026-03-13 |
| 20885632496742 | Halyard | OWENS & MINOR DISTRIBUTION, INC. | NAD | 2026-03-13 |
| 20885632496766 | Halyard | OWENS & MINOR DISTRIBUTION, INC. | NAD | 2026-03-13 |
| 06974843740574 | MemGard | Dalian Orientech Co.,Ltd | NAD | 2026-03-10 |
| 06974843740581 | MemGard | Dalian Orientech Co.,Ltd | NAD | 2026-03-10 |
| 06974843740598 | MemGard | Dalian Orientech Co.,Ltd | NAD | 2026-03-10 |
| 06974843740604 | MemGard | Dalian Orientech Co.,Ltd | NAD | 2026-03-10 |
| 06974843740741 | MemGard | Dalian Orientech Co.,Ltd | NAD | 2026-03-10 |
| 06974843740758 | MemGard | Dalian Orientech Co.,Ltd | NAD | 2026-03-10 |
| 06974843740765 | MemGard | Dalian Orientech Co.,Ltd | NAD | 2026-03-10 |
| 06974843740772 | MemGard | Dalian Orientech Co.,Ltd | NAD | 2026-03-10 |
| 06974843740789 | MemGard | Dalian Orientech Co.,Ltd | NAD | 2026-03-10 |
| 06974843740796 | MemGard | Dalian Orientech Co.,Ltd | NAD | 2026-03-10 |
| 06974843740802 | MemGard | Dalian Orientech Co.,Ltd | NAD | 2026-03-10 |
| 06974843740819 | MemGard | Dalian Orientech Co.,Ltd | NAD | 2026-03-10 |
| 06974843740826 | MemGard | Dalian Orientech Co.,Ltd | NAD | 2026-03-10 |
| 06974843740833 | MemGard | Dalian Orientech Co.,Ltd | NAD | 2026-03-10 |
| 06974843740840 | MemGard | Dalian Orientech Co.,Ltd | NAD | 2026-03-10 |
| 06974843740857 | MemGard | Dalian Orientech Co.,Ltd | NAD | 2026-03-10 |
| 06974843740864 | MemGard | Dalian Orientech Co.,Ltd | NAD | 2026-03-10 |
| 06974843740871 | MemGard | Dalian Orientech Co.,Ltd | NAD | 2026-03-10 |
| 06974843740888 | MemGard | Dalian Orientech Co.,Ltd | NAD | 2026-03-10 |
| 06974843740895 | MemGard | Dalian Orientech Co.,Ltd | NAD | 2026-03-10 |
| 06974843740901 | MemGard | Dalian Orientech Co.,Ltd | NAD | 2026-03-10 |