FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10197106530269
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SEN24FPRBB
Catalog number
SEN24FPRBB
Device description
FACE PACK
Published
2024-01-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
OGABrachial plexus anesthesia kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OGABrachial Plexus Anesthesia KitAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50197106530267PackageGS14In Commercial Distribution
10197106530269PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710653026750197106530267
1019710653026910197106530269

GMDN Terms#

Term, Definition table
TermDefinition
ENT surgical procedure kit, non-medicated, single-useA collection of various sterile ear/nose/throat (ENT) surgical instruments, dressings and the necessary materials used to perform an ENT surgical procedure. It does not contain pharmaceuticals. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature040 Degrees Celsius

Regulatory Flags#

DUNS number
961027315
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10885380213281CARDINAL HEALTHCAH4403CAH44032026-05-27
10192253047486Telfa766776672025-09-08
50885380140233CONVERTORS8337N8337N2018-08-20
10192253047967Kendall92339233-2026-05-26
20192253019992Kendall33547T33547T--2026-05-26
10198956056497CARDINAL HEALTHPN69MSGADPN69MSGAD2026-05-25
10198956057005CARDINAL HEALTHSBACGDPMEDSBACGDPMED2026-05-25
10198956221161CARDINAL HEALTHSOP29PLCCYSOP29PLCCY2026-05-25
10198956253773CARDINAL HEALTHSOP56TKTCCSOP56TKTCC2026-05-25
10198956257610CARDINAL HEALTHSOPOCTKLHKSOPOCTKLHK2026-05-25
10198956258730CARDINAL HEALTHAMN4Q8277CAMN4Q8277C2026-05-25
10198956291812CARDINAL HEALTHSOP4FKPWFBSOP4FKPWFB2026-05-25
10198956300316CARDINAL HEALTH34-2071H34-2071H2026-05-25
10198956321632CARDINAL HEALTHSOPCGKHAUCSOPCGKHAUC2026-05-25
10198956325487CARDINAL HEALTHPO43LEUNCPO43LEUNC2026-05-25
10198956328457CARDINAL HEALTHPG4ETRHTCPG4ETRHTC2026-05-25
10198956340435CARDINAL HEALTH08-4609B08-4609B2026-05-25
10198956345645CARDINAL HEALTHSEYCGVPCPHSEYCGVPCPH2026-05-25
10198956348189CARDINAL HEALTHSBA48PPNSESBA48PPNSE2026-05-25
10198956350205CARDINAL HEALTHORC431774CORC431774C2026-05-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10197106765999CARDINAL HEALTHCardinal Health 200, LLCOGA2024-11-06
50197106765997CARDINAL HEALTHCardinal Health 200, LLCOGA2024-11-06
10197106678404CARDINAL HEALTHCardinal Health 200, LLCOGA2024-06-21
50197106678402CARDINAL HEALTHCardinal Health 200, LLCOGA2024-06-21
10197106624036CARDINAL HEALTHCardinal Health 200, LLCOGA2024-05-07
50197106624034CARDINAL HEALTHCardinal Health 200, LLCOGA2024-05-07
10197106355435CARDINAL HEALTHCardinal Health 200, LLCOGA2023-07-27
50197106355433CARDINAL HEALTHCardinal Health 200, LLCOGA2023-07-27
10195594895341CARDINAL HEALTHCardinal Health 200, LLCOGA2022-10-21
50195594895349CARDINAL HEALTHCardinal Health 200, LLCOGA2022-10-21
10195594857554CARDINAL HEALTHCardinal Health 200, LLCOGA2022-09-30
50195594857552CARDINAL HEALTHCardinal Health 200, LLCOGA2022-09-30
00887488033900CARDINAL HEALTHCardinal Health 200, LLCOGA2016-04-06
50887488033905CARDINAL HEALTHCardinal Health 200, LLCOGA2016-04-06