FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10197106355435
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
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

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
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10198956232792CARDINAL HEALTHSOP3IOLUTASOP3IOLUTA2026-07-16
10198956260016CARDINAL HEALTHSNE23SPMABSNE23SPMAB2026-07-16
10198956319929CARDINAL HEALTHSAN55TPKFCSAN55TPKFC2026-07-16
10198956326484CARDINAL HEALTH03-1708O03-1708O2026-07-16
10198956334342CARDINAL HEALTHPO21FKEGBPO21FKEGB2026-07-16
10198956335523CARDINAL HEALTHSAN19CCKHOSAN19CCKHO2026-07-16
10198956344020CARDINAL HEALTHSCV73OPBHCSCV73OPBHC2026-07-16
10198956359611CARDINAL HEALTHPO24ARSMCPO24ARSMC2026-07-16
10198956360112CARDINAL HEALTHSMA55DPKCSSMA55DPKCS2026-07-16
10198956364837CARDINAL HEALTHPO54KTGCCPO54KTGCC2026-07-16
10198956368002CARDINAL HEALTHSOPHDUPUBDSOPHDUPUBD2026-07-16
10198956382381CARDINAL HEALTHSCV5DPPUMDSCV5DPPUMD2026-07-16
10198956382930CARDINAL HEALTHSEY48CPOELSEY48CPOEL2026-07-16
10198956388178CARDINAL HEALTHSENHDTAHGDSENHDTAHGD2026-07-16
10198956390546CARDINAL HEALTHSEYHDEYSPBSEYHDEYSPB2026-07-16
10198956392755CARDINAL HEALTHSOPOCPPAEBSOPOCPPAEB2026-07-16
10198956395886CARDINAL HEALTHSAN53EPVSFSAN53EPVSF2026-07-16
10198956400856CARDINAL HEALTH08-0077C08-0077C2026-07-16
10198956408401CARDINAL HEALTHSOPVXEXBMESOPVXEXBME2026-07-16
10198956418431CARDINAL HEALTHSAN69BPKIBSAN69BPKIB2026-07-16

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
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