FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
20192253018773
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
4380C
Catalog number
4380C
Device description
COMFORT HOOD -75 EA/BX
Published
2019-06-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
FYFCAP, SURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FYFCap, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50192253018774PackageGS16In Commercial Distribution
20192253018773PrimaryGS10
10192253018776Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019225301877450192253018774
2019225301877320192253018773
1019225301877610192253018776

GMDN Terms#

Term, Definition table
TermDefinition
Surgical hoodA non-sterile head covering designed as a top with elongated sides and back with a front opening for the face to be used by surgical staff to cover their hair and facial hair (beards) in order to protect both the patient and themselves from the transfer of microorganisms, body fluids, and particulate material. It is typically made of soft, disposable materials. This is a single-use device.

Regulatory Flags#

DUNS number
961027315
Device count
75
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10192253047981Kendall923692362026-06-09
10192253047998Kendall923892382026-06-09
10192253048001Kendall923992392026-06-09
10192253048018Kendall924092402026-06-09
10192253048025Kendall924292422026-06-09
10192253048032Kendall924392432026-06-09
10192253046205Webcol511051102024-09-05
10192253047066Webcol68186818-2025-06-10
10192253047073Webcol6818-16818-12025-07-28
10884521008427Dover502750272016-09-24
10885380052538CARDINAL HEALTHC-CB2SC-CB2S2023-08-07
10885380052545CARDINAL HEALTHC-CB3SC-CB3S2023-08-07
10885380052569CARDINAL HEALTHC-CB6SC-CB6S2023-08-07
10885380052613CARDINAL HEALTHC-CB6C-CB62023-08-07
10885380107801CARDINAL HEALTHABP1201ABP12012016-07-22
10885380107818CARDINAL HEALTHASC1201ASC12012016-07-22
10885380107825CARDINAL HEALTHASC1210ASC12102016-07-22
10885380107832CARDINAL HEALTHASC1211ASC12112016-07-22
10885380107849CARDINAL HEALTHASC1220ASC12202016-07-22
10885380107856CARDINAL HEALTHASC1221ASC12212016-07-22

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Primary DI, Brand, Company table
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