FDA.report

CARDINAL HEALTH

Primary DI
10888499007161
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
CAH35LFBK
Catalog number
CAH35LFBK
Device description
BANDAGE COMPRESSION 3IN X 5YD SELF ADHERENT CASE PACK NONSTERILE BLACK
Published
2019-06-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
KGXTape and bandage, adhesive

Product Code Classifications

CodeDeviceSpecialtyClass
KGXTape And Bandage, AdhesiveGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00888499007164PackageGS124In Commercial Distribution
10888499007161PackageGS12In Commercial Distribution
10885380102325PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00888499007164008884990071648884990071640888499007164
1088849900716110888499007161
1088538010232510885380102325

GMDN Terms

TermDefinition
Pressure bandage, non-latex, non-sterile, single-useA non-sterile strip or roll of fabric or plastic material (non-latex) intended to be applied to and compress a local area of the body for one or more preventative/therapeutic applications (e.g., prevent oedema, support injuries associated with minor trauma, treat disorders of venous return). It may be described as a sports tape intended for support while allowing movement, or described as a compression bandage; it is not intended to be used in association with open wounds. It is normally available [non-prescription] over-the-counter (OTC) for use in the home or healthcare facility. This is a single-use device.

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
false
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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