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Cardinal Health

FDA UDI

Class U (US FDA UDI)

by Cardinal Health 200, LLC

Identity

Trade Name
CARDINAL HEALTH FDA UDI
Generic Name
Wound hydrogel dressing, non-sterile FDA UDI
Device Name
Hydrogel Partial to full thickness wounds: -Pressure and stasis ulcers -First- and second-degree burns -Lacerations, cuts, and abrasions -Post-operative incisions -Skin irritations Excellent viscosity Clean, greaseless formulation Cardinal Health Hydrogel is a clean, greaseless hydrogel used for the maintenance of a moist wound environment. Indications: May be used for the management of dry to lightly exuding, partial and full thickness wounds, including pressure and stasis ulcers, first- and second-degree burns, lacerations, cuts, abrasions, skin irritations, post-operative incisions, and conditions with periostomal care. Directions for use: Cleanse wound with appropriate wound cleanser such as Cardinal Health Wound Cleanser. Apply gel approximately 1/4-inch thick to wound bed. Cover with an appropriate secondary dressing. Repeat as often as necessary to keep wound moist. Ingredients: Water, aloe barbadensis leaf juice, glycerin, sorbitol, carbomer, triethanolamine, allantoin, methylparaben, disodium EDTA, imidazolidinyl urea Caution: For external use only. Avoid contact with eyes. If condition worsens or does not improve within 10 to 14 days, consult a physician. In rare instances of local sensitivity, discontinue use. Keep this and all similar products out of the reach of children. If swallowed, seek medical attention or contact a poison control center immediately. Follow directions for use. Store at ambient temperature. FDA UDI
Model / Reference
HG3OZ FDA UDI
Description
Hydrogel Partial to full thickness wounds: -Pressure and stasis ulcers -First- and second-degree burns -Lacerations, cuts, and abrasions -Post-operative incisions -Skin irritations Excellent viscosity Clean, greaseless formulation Cardinal Health Hydrogel is a clean, greaseless hydrogel used for the maintenance of a moist wound environment. Indications: May be used for the management of dry to lightly exuding, partial and full thickness wounds, including pressure and stasis ulcers, first- and second-degree burns, lacerations, cuts, abrasions, skin irritations, post-operative incisions, and conditions with periostomal care. Directions for use: Cleanse wound with appropriate wound cleanser such as Cardinal Health Wound Cleanser. Apply gel approximately 1/4-inch thick to wound bed. Cover with an appropriate secondary dressing. Repeat as often as necessary to keep wound moist. Ingredients: Water, aloe barbadensis leaf juice, glycerin, sorbitol, carbomer, triethanolamine, allantoin, methylparaben, disodium EDTA, imidazolidinyl urea Caution: For external use only. Avoid contact with eyes. If condition worsens or does not improve within 10 to 14 days, consult a physician. In rare instances of local sensitivity, discontinue use. Keep this and all similar products out of the reach of children. If swallowed, seek medical attention or contact a poison control center immediately. Follow directions for use. Store at ambient temperature. FDA UDI

Identifiers

Catalog Number
HG3OZ FDA UDI
Primary DI / UDI-DI
00888499001360 FDA UDI
FDA Product Code
MGQ FDA UDI
GMDN Term
Wound hydrogel dressing, non-sterile FDA UDI

Classification

Device Class
U FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Wound hydrogel dressing, non-sterile

Cardinal Health by Cardinal Health 200, LLC — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Wound hydrogel dressing, non-sterile.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Cardinal Health 200, LLC

Sources (1)

  • FDA UDI 02ebccfc-0b4f-47fa-b493-e243fffcda70 34 fields · synced Jun 8, 2026