CARDINAL HEALTH

Primary DI
10888499001022
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
RGFB66AG
Catalog number
RGFB66AG
Device description
Reinforced Gelling Fiber +Ag 6 x 6 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

CodeName
FRODressing, wound, drug

Product Code Classifications

CodeDeviceSpecialtyClass
FRODressing, Wound, DrugUnknownU

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00888499001025PackageGS15In Commercial Distribution
10888499001022PackageGS110In Commercial Distribution
10885380065095PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00888499001025008884990010258884990010250888499001025
1088849900102210888499001022
1088538006509510885380065095

GMDN Terms

TermDefinition
Exudate-absorbent dressing, hydrophilic-gel, antimicrobial, sterileA 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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