FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10195594534868
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SBACGSPBO2
Catalog number
SBACGSPBO2
Device description
IUS SPINAL PK
Published
2022-02-04
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
50195594534866PackageGS14In Commercial Distribution
10195594534868PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019559453486650195594534866
1019559453486810195594534868

GMDN Terms#

Term, Definition table
TermDefinition
Intrathecal anaesthesia set, non-medicatedA collection of devices intended for the administration of an analgesic or anaesthetic agent (not included) to the intrathecal space for the management of pain (known as spinal block, subarachnoid block, or intradural block). It includes a spinal needle and a syringe, with additional devices utilized for the procedure (e.g., dressings). It is not intended for epidural anaesthesia. 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
10198956465718CARDINAL HEALTHCardinal Health 200, LLCOFU2026-07-06
10198956507159CARDINAL HEALTHCardinal Health 200, LLCOFU2026-06-23
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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
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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