FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50197106355433
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SEN54ENUNA
Catalog number
SEN54ENUNA
Device description
ENT PACK
Published
2023-07-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
50197106355433PackageGS13In Commercial Distribution
10197106355435PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710635543350197106355433
1019710635543510197106355435

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
961027315
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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
10197106530269CARDINAL HEALTHCardinal Health 200, LLCOGA2024-01-10
10197106355435CARDINAL 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