CARDINAL HEALTH
- Primary DI
- 10888499001039
- Brand
- CARDINAL HEALTH
- Company
- Cardinal Health 200, LLC
- Model
- RGFB812AG
- Catalog number
- RGFB812AG
- Device description
- Reinforced Gelling Fiber +Ag 8 x 12 in. Dressing Partial to full thickness wounds: -Pressure ulcers -Leg ulcers -Diabetic ulcers -Post-operative surgical wounds -First- and second-degree burns -Graft and donor sites -Trauma wounds (dermal lesions, trauma injuries or incisions) Highly absorbent gelling fibers Cohesive fiber construction Effective antimicrobial silver Directions for use: 1. Clean wound area with an appropriate wound cleanser such as Cardinal Health Wound Cleanser or normal saline solution. Dry surrounding skin thoroughly. 2. Remove dressing from packaging and if necessary cut dressing to size using sterile scissors. 3. Apply dressing over the wound bed leaving a 1/2-inch overlap. If wound is deep, loosely fill wound ensuring that the dressing does not overlap wound margins. Product will expand to fill the empty wound space once in contact with the exudate. Dressing can be pre-moistened with room temperature sterile water or saline solution before application. 4. Cover wound and this primary dressing with a non-occlusive secondary dressing to promote a moist wound healing environment. 5. All dressings should be monitored frequently. Remove dressing when clinically indicated, such as leakage, excessive bleeding, increased pain, or after a maximum of 7 days. Indications May be used for the management of moderate to heavy exuding, partial to full thickness wounds including: -Pressure ulcers -Leg ulcers -Diabetic ulcers -Post-operative surgical wounds -First- and second-degree burns -Graft and donor sites -Trauma wounds (dermal lesions, trauma injuries or incisions)
- Published
- 2019-06-25
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- true
- Single use
- true
Related Records
Product Codes
| Code | Name |
|---|---|
| FRO | Dressing, wound, drug |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| FRO | Dressing, Wound, Drug | Unknown | U |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00888499001032 | Package | GS1 | 5 | In Commercial Distribution |
| 10888499001039 | Package | GS1 | 10 | In Commercial Distribution |
| 10885380065101 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00888499001032 | 00888499001032 | 888499001032 | 0888499001032 |
| 10888499001039 | 10888499001039 | ||
| 10885380065101 | 10885380065101 |
GMDN Terms
| Term | Definition |
|---|---|
| Exudate-absorbent dressing, hydrophilic-gel, antimicrobial, sterile | A sterile wound covering, typically made of a hydrocolloid, hydrofibre, or alginate (salts and acids extracted from seaweed), intended to produce a water-absorbent gel upon contact with wound exudate, and that contains an antimicrobial agent [e.g., silver (Ag), honey]. It assists in wound healing by absorbing exudate in wounds (e.g., ulcers, burns, surgical wounds, lacerations, abrasions) for minimal wound maceration, allowing wound debridement, and creating a moist wound-healing environment while reducing microbial colonization within the dressing. The device may be in the form of a flat sheet/film, ribbon, rope, foam, liquid, or powder. After application, this device cannot be reused. |
Sterilization Methods
| Method |
|---|
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
- true
- Sterilization required before use
- false
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