CARDINAL HEALTH

Primary DI
10885380065323
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
FMTRACH
Catalog number
FMTRACH
Device description
Cardinal HealthNon-Adhesive Foam Tracheostomy3.5 x 3.5in. DressingManagement of fluid, secretion, or exudate build-up for the peristomal area created by: -Tracheostomy tubes-Other drains and tubesHighly absorbent foam badProtective film backingNon-adherent, fenestrated shapeDirections for use: 1. Clean wound area with appropriate wound cleanser such as Cardinal Health Wound Cleanser. Prepare and clean the skin surrounding the tracheostomy tube by removing excess moisture.2. Remove dressing from packaging and fit dressing around the stoma or tracheostomy tube. Apply the white side towards the patient's skin. Dressing may be cut to shape for a better fit.3. Additional fixation such as Cardinal Health Transparent Film or Tape may be used to secure the dressing.4. All dressings should be monitored frequently. Dressings can be left in place for up to 7 days, or until visible drainage is 3/4 inch from the edge of the dressing. Remove dressing when clinically indicated, such as leakage or increased pain.Not made with natural rubber latexIndicationsManagement of fluid, secretion or exudate build-up for the peristomal area created by: -Tracheostomy tubes-Other drains and tubes
Published
2019-05-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
NADDressing, wound, occlusive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NADDressing, Wound, OcclusiveGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888499001148PackageGS15In Commercial Distribution
10888499001145PackageGS15In Commercial Distribution
10885380065323PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888499001148008884990011488884990011480888499001148
1088849900114510888499001145
1088538006532310885380065323

GMDN Terms#

Term, Definition table
TermDefinition
Cavity-wound management dressing, non-antimicrobialA non-bioabsorbable material or substance designed to be inserted into a wound bed to create an appropriate environment for healing (e.g., warm, moist, absorbent); it does not include an antimicrobial agent(s). It is typically used for the management of deep secondary-healing wounds, particularly for indications such as stage III and IV pressure ulcers, deep leg ulcers, cavity wounds, excisions, and post-op wound dehiscence. It is often designed to conform to the wound bed to support tissues and is often nonadherent to provide for patient comfort during wound management. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius35 Degrees Celsius

Regulatory Flags#

DUNS number
961027315
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

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10192253072723Curity8441268441262026-10-08
10192253072730Curity8441368441362026-10-08
10192253072747Curity8441468441462026-10-08
10192253072754Curity8441568441562026-10-08
10192253072761Curity8441668441662026-10-08
10192253072778Curity8441768441762026-10-08
10192253072785Curity8442168442162026-10-08
10192253072792Curity8442268442262026-10-08
10192253072808Curity8442368442362026-10-08
10192253072815Curity8442468442462026-10-08
10192253072822Curity8442568442562026-10-08
10885380207150Curity4100A4100A2026-10-08
10885380207167Curity4101A4101A2026-10-08
10885380207174Curity4102A4102A2026-10-08
50885380207202Curity41000410002026-10-08
50885380207219Curity4103A4103A2026-10-08
50885380207226Curity4104A4104A2026-10-08
50885380207233Curity4105A4105A2026-10-08
50885380207240Curity42000420002026-10-08
50885380207257Curity43000430002026-10-08

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