FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956468665
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
34-4753H
Catalog number
34-4753H
Device description
SPINAL EPIDURAL TRAY
Published
2026-06-03
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
OFTSpinal epidural anesthesia kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OFTSpinal Epidural Anesthesia KitAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50198956468663PackageGS155In Commercial Distribution
10198956468665PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895646866350198956468663
1019895646866510198956468665

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 Temperature00

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
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20885380173544Curity9022G9022G2019-11-14
20885380173568Curity9024G9024G2019-11-14
10198956038127CARDINAL HEALTHSAN22IAMRASAN22IAMRA2026-10-19
10198956180000CARDINAL HEALTHPUV2KPMHBPUV2KPMHB2026-10-19
10198956268111CARDINAL HEALTHSNECGACSGESNECGACSGE2026-10-19
10198956377967CARDINAL HEALTHSBA56MIMCFSBA56MIMCF2026-10-19
10198956384774CARDINAL HEALTHSVA42LVGLCSVA42LVGLC2026-10-19
10198956390799CARDINAL HEALTHSEYCGEPAZBSEYCGEPAZB2026-10-19
10198956400795CARDINAL HEALTHSOP3MKPCVDSOP3MKPCVD2026-10-19
10198956414815CARDINAL HEALTHSMA41PGEPBSMA41PGEPB2026-10-19
10198956441811CARDINAL HEALTHSCV29VPPCUSCV29VPPCU2026-10-19
10198956462328CARDINAL HEALTHSCV13PPBTESCV13PPBTE2026-10-19
10198956464988CARDINAL HEALTHSOP51XRKKPSOP51XRKKP2026-10-19
10198956499270CARDINAL HEALTHPG33BGMKBPG33BGMKB2026-10-19
10198956499980CARDINAL HEALTH33-2528E33-2528E2026-10-19
10198956506732CARDINAL HEALTHSOP41TPDSFSOP41TPDSF2026-10-19
10198956513587CARDINAL HEALTHSAN33CACHNSAN33CACHN2026-10-19
10198956514874CARDINAL HEALTHSOPOCTKSBBSOPOCTKSBB2026-10-19
10198956516922CARDINAL HEALTHPC23TAAMEPC23TAAME2026-10-19
10198956518964CARDINAL HEALTHSAN40CCAEGSAN40CCAEG2026-10-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956599208CARDINAL HEALTHCardinal Health 200, LLCOFT2026-10-15
04046955966233Design Options®B. BRAUN MEDICAL INC.OFT2026-08-17
10198956530652CARDINAL HEALTHCardinal Health 200, LLCOFT2026-07-27
10193489437966Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFT2023-07-29
10193489211931Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFT2023-06-08
10193489213485Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFT2023-06-08
10193489214369Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFT2023-06-08
10193489214468Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFT2023-06-08
10193489215373Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFT2023-06-08
10193489215878Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFT2023-06-08
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10193489422344Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFT2023-06-08
10193489422443Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFT2023-06-08
10193489423396Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFT2023-06-08
10193489425277Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFT2023-06-08
10193489425284Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFT2023-06-08
10193489429909Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFT2023-06-08
10193489432008Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFT2023-06-08
10193489432022Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFT2023-06-08
10193489441420Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFT2023-06-08
10193489441604Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFT2023-06-08