FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10197106980248
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SAN36IREA1
Catalog number
SAN36IREA1
Device description
EAS IR PACK
Published
2025-03-14
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
50197106980246PackageGS14In Commercial Distribution
10197106980248PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710698024650197106980246
1019710698024810197106980248

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
10192253024456Argyle888472450488847245042026-10-09
10192253024463Argyle888825860888882586082026-10-09
10192253050783Argyle888686430488868643042026-10-09
10192253050790Argyle888686460488868646042026-10-09
10192253050806Argyle888825736088882573602026-10-09
10192253050813Argyle888825737888882573782026-10-09
10192253050820Argyle888825738688882573862026-10-09
10192253050837Argyle888825746988882574692026-10-09
10192253050844Argyle888825747788882574772026-10-09
10192253050851Argyle888825748588882574852026-10-09
10192253050868Argyle888825752788882575272026-10-09
10192253050875Argyle888825753588882575352026-10-09
10192253050882Argyle888825755088882575502026-10-09
10885380214813DermaceaWD6112WD61122026-10-09
10885380214820DermaceaWD6113WD61132026-10-09
10885380214837DermaceaWD6114WD61142026-10-09
10885380214844DermaceaWD6115WD61152026-10-09
10885380214851DermaceaWD6116WD61162026-10-09
20885380157339FLEXAL88RT01XS88RT01XS2018-09-21
20885380157346FLEXAL88RT02S88RT02S2018-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956397859CARDINAL HEALTHCardinal Health 200, LLCOFU2026-10-06
10198956576100CARDINAL HEALTHCardinal Health 200, LLCOFU2026-09-25
10198956381100CARDINAL HEALTHCardinal Health 200, LLCOFU2026-08-18
10198956465718CARDINAL HEALTHCardinal Health 200, LLCOFU2026-07-06
10198956507159CARDINAL HEALTHCardinal Health 200, LLCOFU2026-06-23
10198956444461CARDINAL HEALTHCardinal Health 200, LLCOFU2026-05-08
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
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
10197106955468CARDINAL HEALTHCardinal Health 200, LLCOFU2025-03-11