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

CodeName
FRODressing, wound, drug

Product Code Classifications

CodeDeviceSpecialtyClass
FRODressing, Wound, DrugUnknownU

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20888499001043PackageGS110In Commercial Distribution
30888499001040PackageGS14In Commercial Distribution
00888499001049PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
2088849900104320888499001043
3088849900104030888499001040
00888499001049008884990010498884990010490888499001049

GMDN Terms

TermDefinition
Wound hydrogel dressing, sterile, antimicrobialA 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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