FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956444461
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SAN36IREAC
Catalog number
SAN36IREAC
Device description
EAS IR PACK
Published
2026-05-08
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
OFUSpinal anesthesia kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OFUSpinal Anesthesia KitAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50198956444469PackageGS14In Commercial Distribution
10198956444461PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895644446950198956444469
1019895644446110198956444461

GMDN Terms#

Term, Definition table
TermDefinition
Peripheral anaesthesia single-administration set, medicatedA collection of devices intended for the single-administration of an anaesthetic agent to function as a peripheral nerve-block. It includes a pharmaceutical anaesthetic agent with an anaesthesia needle and a syringe often with additional devices utilized for the procedure (e.g., dressings); as a single-administration set it does not include a catheter. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 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
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
10198956354517CARDINAL HEALTHSOP44TSTODSOP44TSTOD2026-05-25
10198956358003CARDINAL HEALTHSOT53CYPZDSOT53CYPZD2026-05-25
10198956358904CARDINAL HEALTHSOP53ACVLFSOP53ACVLF2026-05-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956457812CARDINAL HEALTHCardinal Health 200, LLCOFU2026-05-04
10198956444362CARDINAL HEALTHCardinal Health 200, LLCOFU2026-04-21
10198956407107CARDINAL HEALTHCardinal Health 200, LLCOFU2026-04-14
10198956359833CARDINAL HEALTHCardinal Health 200, LLCOFU2026-04-06
10198956359321CARDINAL HEALTHCardinal Health 200, LLCOFU2026-03-23
10198956406803CARDINAL HEALTHCardinal Health 200, LLCOFU2026-03-23
10198956421172CARDINAL HEALTHCardinal Health 200, LLCOFU2026-03-23
10198956393349CARDINAL HEALTHCardinal Health 200, LLCOFU2026-03-19
10198956364622CARDINAL HEALTHCardinal Health 200, LLCOFU2026-02-09
10198956238732CARDINAL HEALTHCardinal Health 200, LLCOFU2026-01-22
10198956343603CARDINAL HEALTHCardinal Health 200, LLCOFU2026-01-22
10198956270749CARDINAL HEALTHCardinal Health 200, LLCOFU2025-12-29
10198956266513CARDINAL HEALTHCardinal Health 200, LLCOFU2025-12-26
04046955331802Design Options®B. BRAUN MEDICAL INC.OFU2025-11-23
10198956248595CARDINAL HEALTHCardinal Health 200, LLCOFU2025-11-06
10198956139978CARDINAL HEALTHCardinal Health 200, LLCOFU2025-10-13
10198956124639CARDINAL HEALTHCardinal Health 200, LLCOFU2025-10-03
10198956169593CARDINAL HEALTHCardinal Health 200, LLCOFU2025-08-13
10198956133693CARDINAL HEALTHCardinal Health 200, LLCOFU2025-07-21
10198956099630CARDINAL HEALTHCardinal Health 200, LLCOFU2025-06-20
10198956080652CARDINAL HEALTHCardinal Health 200, LLCOFU2025-06-10
10197106924136CARDINAL HEALTHCardinal Health 200, LLCOFU2025-04-03
10198956009653CARDINAL HEALTHCardinal Health 200, LLCOFU2025-03-31
10198956007246CARDINAL HEALTHCardinal Health 200, LLCOFU2025-03-25
10197106980248CARDINAL HEALTHCardinal Health 200, LLCOFU2025-03-14
10197106955468CARDINAL HEALTHCardinal Health 200, LLCOFU2025-03-11
10197106839355CARDINAL HEALTHCardinal Health 200, LLCOFU2025-03-10
10197106938515CARDINAL HEALTHCardinal Health 200, LLCOFU2025-02-28
10197106951989CARDINAL HEALTHCardinal Health 200, LLCOFU2025-02-21
10197106882955CARDINAL HEALTHCardinal Health 200, LLCOFU2025-02-03