CARDINAL HEALTH

Primary DI
10888499001152
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
BFM22LTE
Catalog number
BFM22LTE
Device description
Cardinal Health Silicone Bordered Foam Lite 1.6 x 2in. Dressing Partial to full thickness wounds: -Pressure ulcers -Traumatic wounds -Venous, arterial and diabetic ulcers -Finger injuries -Blisters -Partial thickness burns -Epidermolysis bullosa Absorbent thin foam pad Gentle silicone adhesive Protective film backing Secure border Directions for use: 1. Clean wound with appropriate wound cleanser such as Cardinal Health Wound Cleanser. Dry surrounding skin thoroughly. Skin barrier products are not necessary. 2. Remove dressing from packaging. For dressings smaller than 5x5 inches, there should be a 3/4-inch overlap onto the dry skin surrounding the wound. For dressings larger than 5x5 inches, there should be a 2-inch overlap. Do not stretch or cut product. 3. Apply adherent side of dressing over wound considering the overlap recommendations to protect the surrounding skin. Secondary dressing or additional fixation is not necessary. 3. All dressings should be monitored frequently. Remove dressing when clinically indicated, such as leakage or increased pain, or after a maximum of 7 days. Not made with natural rubber latex Indications: May be used for the management of moderate to heavy exuding, partial to full thickness wounds, including: -Pressure ulcers -Traumatic wounds -Venous, arterial and diabetic ulcers -Finger injuries -Blisters -Partial thickness burns -Epidermolysis bullosa Can also be used to provide protection of compromised and/or fragile skin.
Published
2019-05-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
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
00888499001155PackageGS110In Commercial Distribution
10888499001152PackageGS15In Commercial Distribution
10885380065330PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888499001155008884990011558884990011550888499001155
1088849900115210888499001152
1088538006533010885380065330

GMDN Terms#

Term, Definition table
TermDefinition
Cavity-wound management dressingA 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 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

Sterilization Methods#

Method table
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
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10198956339729CARDINAL HEALTHSBA22ATMRASBA22ATMRA2026-09-25
10198956374232CARDINAL HEALTHSOP41KASRBSOP41KASRB2026-09-25
10198956383043CARDINAL HEALTHORC3R7765BORC3R7765B2026-09-25
10198956388239CARDINAL HEALTHSOT53CYPOFSOT53CYPOF2026-09-25
10198956393288CARDINAL HEALTHSBA73GPMVBSBA73GPMVB2026-09-25
10198956400801CARDINAL HEALTHSOP3MHPCVCSOP3MHPCVC2026-09-25
10198956402522CARDINAL HEALTHSMA13GLEXDSMA13GLEXD2026-09-25
10198956424654CARDINAL HEALTHPO54TKCMDPO54TKCMD2026-09-25
10198956439849CARDINAL HEALTHSAN69PCKOGSAN69PCKOG2026-09-25
10198956444263CARDINAL HEALTHPV36HPCHEPV36HPCHE2026-09-25
10198956450684CARDINAL HEALTHSMA58CSLOPSMA58CSLOP2026-09-25
10198956461086CARDINAL HEALTHSBACGBPGSHSBACGBPGSH2026-09-25
10198956462205CARDINAL HEALTHPV08TCGHHPV08TCGHH2026-09-25
10198956466159CARDINAL HEALTH03-2656S03-2656S2026-09-25
10198956466838CARDINAL HEALTHSNE35LSFSGSNE35LSFSG2026-09-25
10198956484382CARDINAL HEALTHANE306276AANE306276A2026-09-25

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