FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
00888499001346
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
WC8OZ
Catalog number
WC8OZ
Device description
Wound CleanserNo-rinse, non-irritating formulationNon-ionic surfactantDirections for use: 1. Turn nozzle to stream or spray position.2. Spray contents on area to be cleansed approximately 3 inches away.Ingredients: Purified water, poloxamer 188, sodium bicarbonate, sorbitol, citric acid, disodium EDTA, methylparaben, imidazolidinyl ureaIndications: May be used for the removal of foreign materials such as dirt and debris from dermal wounds.Caution: For external use only. Keep this and all similar products out of the reach of children.Store at ambient temperature.
Published
2019-05-16
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
FRODressing, wound, drug

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRODressing, Wound, DrugUnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10888499001343PackageGS112Not in Commercial Distribution
00888499001346PrimaryGS10
00885380171867Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088849900134310888499001343
00888499001346008884990013468884990013460888499001346
00885380171867008853801718678853801718670885380171867

GMDN Terms#

Term, Definition table
TermDefinition
Skin detergentA non-dedicated chemical solution intended to be applied to the surface of the skin for cleaning and/or conditioning, and is commonly used to remove dirt, debris, peeling skin, and/or for the attenuation of minor skin disorders (e.g., dry skin). It contains a synthetic surfactant (e.g., sodium laureth sulfate) and is normally available [non-prescription] over-the-counter (OTC) for home-use. After application, this device cannot be reused.

Regulatory Flags#

DUNS number
961027315
Device count
8
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10198956037908CARDINAL HEALTH08-3641G08-3641G2026-09-04
10198956210240CARDINAL HEALTHAMN213116EAMN213116E2026-09-04
10198956310933CARDINAL HEALTHANE439532GANE439532G2026-09-04
10198956331891CARDINAL HEALTHSAN13ARBIFSAN13ARBIF2026-09-04
10198956333420CARDINAL HEALTHSANX4IPSSCSANX4IPSSC2026-09-04
10198956359291CARDINAL HEALTHSMA54BGEVCSMA54BGEVC2026-09-04
10198956379084CARDINAL HEALTHSOP33EXMSGSOP33EXMSG2026-09-04
10198956395947CARDINAL HEALTHSOPMIMPMSBSOPMIMPMSB2026-09-04
10198956398467CARDINAL HEALTHSBA44LPCEASBA44LPCEA2026-09-04
10198956415195CARDINAL HEALTHSCVCGOHILHSCVCGOHILH2026-09-04
10198956421462CARDINAL HEALTHSOPMVSAUCJSOPMVSAUCJ2026-09-04
10198956426061CARDINAL HEALTHSCVDKMVOGDSCVDKMVOGD2026-09-04
10198956428102CARDINAL HEALTHSAN13RDEMSSAN13RDEMS2026-09-04
10198956454989CARDINAL HEALTHSOP23KPNLCSOP23KPNLC2026-09-04
10198956462977CARDINAL HEALTHSBA48LCRHCSBA48LCRHC2026-09-04
10198956463394CARDINAL HEALTHSEN23TAPCLSEN23TAPCL2026-09-04
10198956464520CARDINAL HEALTHSMA23GPNVBSMA23GPNVB2026-09-04
10198956465510CARDINAL HEALTH34-3217C34-3217C2026-09-04
10198956468399CARDINAL HEALTHPO1DTHAMQPO1DTHAMQ2026-09-04
10198956468481CARDINAL HEALTHSMAOCGLSTGSMAOCGLSTG2026-09-04

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