FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10197106627303
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
34-4753C
Catalog number
34-4753C
Device description
SPINAL EPIDURAL TRAY
Published
2024-05-16
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
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
50197106627301PackageGS155In Commercial Distribution
10197106627303PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710662730150197106627301
1019710662730310197106627303

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 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
10192253004649Monoject8602RC8602RC2026-07-09
10192253004656Monoject8605RC8605RC2026-07-09
10192253004663Monoject8607RC8607RC2026-07-09
10192253004700Monoject8617RC8617RC2026-07-09
10192253051575Precision2650SA2650SA2026-07-09
10197106896327CARDINAL HEALTHSNENU0868BSNENU0868B2026-07-09
10198956074668CARDINAL HEALTHSBA37OTMOFSBA37OTMOF2026-07-09
10198956119260CARDINAL HEALTHSBA69MPSUBSBA69MPSUB2026-07-09
10198956119437CARDINAL HEALTHPVVMVPBLGPVVMVPBLG2026-07-09
10198956255586CARDINAL HEALTHSOP53SAPTHSOP53SAPTH2026-07-09
10198956268272CARDINAL HEALTHSMA54CSWMMSMA54CSWMM2026-07-09
10198956286719CARDINAL HEALTHSOT11BR10MSOT11BR10M2026-07-09
10198956307308CARDINAL HEALTHSAN43ADSWOSAN43ADSWO2026-07-09
10198956313576CARDINAL HEALTHSMA69BTDNBSMA69BTDNB2026-07-09
10198956333888CARDINAL HEALTHPBCGLSARGPBCGLSARG2026-07-09
10198956334373CARDINAL HEALTHSNECGBPNODSNECGBPNOD2026-07-09
10198956339132CARDINAL HEALTHSEYHDCAGWHSEYHDCAGWH2026-07-09
10198956345942CARDINAL HEALTHSANOCIRHTBSANOCIRHTB2026-07-09
10198956349834CARDINAL HEALTHSAN73PLCHMSAN73PLCHM2026-07-09
10198956360358CARDINAL HEALTHSCV73VPBHDSCV73VPBHD2026-07-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956468665CARDINAL HEALTHCardinal Health 200, LLCOFT2026-06-03
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
10193489216233Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFT2023-06-08
10193489412222Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFT2023-06-08
10193489413717Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFT2023-06-08
10193489414288Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFT2023-06-08
10193489414745Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFT2023-06-08
10193489414752Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFT2023-06-08
10193489417821Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFT2023-06-08
10193489418057Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFT2023-06-08
10193489419092Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFT2023-06-08
10193489422313Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFT2023-06-08
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
10193489445398Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFT2023-06-08
10193489445404Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFT2023-06-08