FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50197106624034
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SEN35TAEAA
Catalog number
SEN35TAEAA
Device description
T AND A PACK
Published
2024-05-07
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
50197106624034PackageGS14In Commercial Distribution
10197106624036PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710662403450197106624034
1019710662403610197106624036

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.

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
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10198956106666CARDINAL HEALTHSAN23PMPRHSAN23PMPRH2026-10-23
10198956201606CARDINAL HEALTHPOV2ASNULPOV2ASNUL2026-10-23
10198956318748CARDINAL HEALTHSAN42RPIRBSAN42RPIRB2026-10-23
10198956332553CARDINAL HEALTHPNVNNECHVPNVNNECHV2026-10-23
10198956409552CARDINAL HEALTHSCV40CVKUGSCV40CVKUG2026-10-23
10198956433113CARDINAL HEALTHSEN40EPWEDSEN40EPWED2026-10-23
10198956460942CARDINAL HEALTHSBA69BPSABSBA69BPSAB2026-10-23
10198956463417CARDINAL HEALTHPB41GLLAEPB41GLLAE2026-10-23
10198956487918CARDINAL HEALTHSOPHDTPMSCSOPHDTPMSC2026-10-23
10198956504899CARDINAL HEALTHSNE12CRKGOSNE12CRKGO2026-10-23
10198956505766CARDINAL HEALTHSOPCNARCRESOPCNARCRE2026-10-23
10198956506572CARDINAL HEALTHSOT7ECPSSESOT7ECPSSE2026-10-23
10198956508682CARDINAL HEALTHSOP53TPNABSOP53TPNAB2026-10-23
10198956530157CARDINAL HEALTHSAN11IRLVLSAN11IRLVL2026-10-23
10198956530799CARDINAL HEALTH34-0748B34-0748B2026-10-23
10198956534834CARDINAL HEALTHSANOCCCPOFSANOCCCPOF2026-10-23
10198956544123CARDINAL HEALTHPG08GMPCBPG08GMPCB2026-10-23
10198956548923CARDINAL HEALTHSNE33SPMACSNE33SPMAC2026-10-23
10198956549524CARDINAL HEALTHSBA11LYMMJSBA11LYMMJ2026-10-23
10198956553552CARDINAL HEALTHSOP41TPSGGSOP41TPSGG2026-10-23

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
10197106530269CARDINAL HEALTHCardinal Health 200, LLCOGA2024-01-10
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