FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10195594890018
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
34-8954D
Catalog number
34-8954D
Device description
EPIDURAL TRAY
Published
2023-01-19
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
OGEEpidural anesthesia kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OGEEpidural Anesthesia KitAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50195594890016PackageGS120In Commercial Distribution
10195594890018PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019559489001650195594890016
1019559489001810195594890018

GMDN Terms#

Term, Definition table
TermDefinition
Epidural anaesthesia set, non-medicatedA collection of devices intended for the administration of an analgesic or anaesthetic agent (not included) to the epidural space for the management of pain. It includes a needle and/or a catheter with additional procedural devices (e.g., syringe, dressings, guidewire, introducer), and may be intended for single- or continuous-administration. It is not intended for intrathecal 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
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10198956182004CARDINAL HEALTHSOPCNEPBSFSOPCNEPBSF2026-07-06
10198956202320CARDINAL HEALTH34-9397L34-9397L2026-07-06
10198956261952CARDINAL HEALTH08-1780F08-1780F2026-07-06
10198956331235CARDINAL HEALTH32-7479R32-7479R2026-07-06
10198956358942CARDINAL HEALTHSEN4LTAGRCSEN4LTAGRC2026-07-06
10198956373068CARDINAL HEALTHSOP53HIOHCSOP53HIOHC2026-07-06
10198956373655CARDINAL HEALTHSANCGANMWCSANCGANMWC2026-07-06
10198956380615CARDINAL HEALTHENDDK4659DENDDK4659D2026-07-06
10198956381124CARDINAL HEALTH34-0950C34-0950C2026-07-06
10198956388789CARDINAL HEALTHSMA11DCWNFSMA11DCWNF2026-07-06
10198956389007CARDINAL HEALTHSEN35ENCFDSEN35ENCFD2026-07-06
10198956393424CARDINAL HEALTHSBADHLPNVCSBADHLPNVC2026-07-06
10198956397361CARDINAL HEALTHSAN29MY87ISAN29MY87I2026-07-06
10198956398689CARDINAL HEALTHSAN3MARCVCSAN3MARCVC2026-07-06
10198956407053CARDINAL HEALTHSOP69TJMSBSOP69TJMSB2026-07-06
10198956414693CARDINAL HEALTHSOP48TKLODSOP48TKLOD2026-07-06
10198956416079CARDINAL HEALTHPN11SF36DPN11SF36D2026-07-06
10198956416482CARDINAL HEALTHSAN11CC26CSAN11CC26C2026-07-06
10198956423077CARDINAL HEALTHPBCGDCBLIPBCGDCBLI2026-07-06
10198956427198CARDINAL HEALTHSBA13SMBTBSBA13SMBTB2026-07-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956458529CARDINAL HEALTHCardinal Health 200, LLCOGE2026-07-06
10198956518698CARDINAL HEALTHCardinal Health 200, LLCOGE2026-07-06
B098AMS10930A0Aligned Medical SolutionsAligned Medical SolutionsOGE2026-07-03
10198956466104CARDINAL HEALTHCardinal Health 200, LLCOGE2026-06-08
10198956483255CARDINAL HEALTHCardinal Health 200, LLCOGE2026-06-03
04046955862634Design Options®B. BRAUN MEDICAL INC.OGE2026-06-01
04046955966264Design Options®B. BRAUN MEDICAL INC.OGE2026-06-01
10198956316096CARDINAL HEALTHCardinal Health 200, LLCOGE2026-06-01
10193489431926Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGE2023-06-08
10195594691356CARDINAL HEALTHCardinal Health 200, LLCOGE2023-04-04
10195594804459CARDINAL HEALTHCardinal Health 200, LLCOGE2023-01-25
10195594766177CARDINAL HEALTHCardinal Health 200, LLCOGE2023-01-17
10195594869885CARDINAL HEALTHCardinal Health 200, LLCOGE2022-12-23
10195594877330CARDINAL HEALTHCardinal Health 200, LLCOGE2022-12-21
10195594679170CARDINAL HEALTHCardinal Health 200, LLCOGE2022-12-15
10195594839109CARDINAL HEALTHCardinal Health 200, LLCOGE2022-12-14
10195594879273CARDINAL HEALTHCardinal Health 200, LLCOGE2022-11-29
10195594840907CARDINAL HEALTHCardinal Health 200, LLCOGE2022-11-10
10197106010365CARDINAL HEALTHCardinal Health 200, LLCOGE2022-11-04
10195594883997CARDINAL HEALTHCardinal Health 200, LLCOGE2022-10-31
10195594856885CARDINAL HEALTHCardinal Health 200, LLCOGE2022-10-27
10195594877187CARDINAL HEALTHCardinal Health 200, LLCOGE2022-10-27
10197106010082CARDINAL HEALTHCardinal Health 200, LLCOGE2022-10-27
10195594839079CARDINAL HEALTHCardinal Health 200, LLCOGE2022-10-25
10195594853952CARDINAL HEALTHCardinal Health 200, LLCOGE2022-10-20
10195594795320CARDINAL HEALTHCardinal Health 200, LLCOGE2022-10-19
10195594885946CARDINAL HEALTHCardinal Health 200, LLCOGE2022-10-14
10195594870096CARDINAL HEALTHCardinal Health 200, LLCOGE2022-10-13
10195594886318CARDINAL HEALTHCardinal Health 200, LLCOGE2022-10-11
10195594811242CARDINAL HEALTHCardinal Health 200, LLCOGE2022-10-10