CARDINAL HEALTH
- Primary DI
- 20888499001043
- Brand
- CARDINAL HEALTH
- Company
- Cardinal Health 200, LLC
- Model
- HG15OZAG
- Catalog number
- HG15OZAG
- Device description
- Hydrogel +Ag Effective Antimicrobial silver Easy application Partial to full thickness wounds: -Pressure ulcers -Graft and donor sites -Leg ulcers -Post-operative surgical wounds -Lacerations and abrasions -Diabetic ulcers -First- and second-degree burns -Trauma wounds Cardinal Health Hydrogel +Ag is an opaque, amorphous hydrogel containing an antimicrobial silver compound that is an effective barrier to bacterial penetration by inhibiting the growth of a broad spectrum of microorganisms that come into contact with the gel. Indications: Under the medical supervision of a healthcare professional for the management of dry to moderately exuding, partial and full thickness wounds, including pressure ulcers, graft and donor sites, leg ulcers, post-operative surgical wounds, lacerations, abrasions, diabetic ulcers, first- and second-degree burns, and trauma wounds (dermal lesions, trauma injuries or incisions). Contraindications: Do not use on patients with a known sensitivity to silver or propylene glycol. Caution: Frequent or prolonged use of this preparation may result in permanent discoloration of skin and mucous membranes. Directions for use: Cleanse wound with appropriate wound cleanser such as Cardinal Health Wound Cleanser. Apply wound gel onto the wound bed, approximately 0.2 inches thick, ensuring wound gel does not cover healthy skin. Cover with an appropriate secondary dressing. Dressing may be left in place for up to 3 days. Please discard the tube and remaining gel 28 days after opening. External use only. Ingredients: water, propylene glycol, guar gum, mono potassium phosphate, silver carbonate, sodium chloride
- 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
- false
- 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 |
|---|---|---|---|---|
| 20888499001043 | Package | GS1 | 10 | In Commercial Distribution |
| 30888499001040 | Package | GS1 | 4 | In Commercial Distribution |
| 00888499001049 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 20888499001043 | 20888499001043 | ||
| 30888499001040 | 30888499001040 | ||
| 00888499001049 | 00888499001049 | 888499001049 | 0888499001049 |
GMDN Terms
| Term | Definition |
|---|---|
| Wound hydrogel dressing, sterile, antimicrobial | A sterile wound covering typically made of cross-linked polymer gels in sheet form or an amorphous hydrating gel of various formulations, and that includes an antimicrobial agent, intended to promote wound healing (e.g., by maintaining a moist wound environment); it may also facilitate wound debridement and/or absorb exudates in wounds that are minimally to moderately exudative. It may combine hydrogel with supplemental dressing materials (e.g., alginate, chitosan, film backing), require the use of a secondary dressing, and/or provide a barrier impermeable to liquids and gases. 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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