FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50197106765980
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
34A8545A
Catalog number
34A8545A
Device description
EPIDURAL SPINAL TRAY
Published
2024-11-06
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
50197106765980PackageGS136In Commercial Distribution
10197106765982PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710676598050197106765980
1019710676598210197106765982

GMDN Terms#

Term, Definition table
TermDefinition
Intrathecal anaesthesia set, medicatedA collection of devices intended for the single-administration of an analgesic or anaesthetic agent to the intrathecal space for the management of pain (known as spinal block, subarachnoid block, or intradural block). It includes the pharmaceutical anaesthetic agent, 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

Sterilization Methods#

Method table
Method

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
10192253047967Kendall92339233-2026-05-26
20192253017615Medi-Trace Cadence22661PC22661PC2021-07-29
20192253019992Kendall33547T33547T--2026-05-26
20885380136617CARDINAL HEALTHN8830N88302019-02-07
20885380136624CARDINAL HEALTHN8831N88312019-02-07
20885380136631CARDINAL HEALTHN8832N88322019-02-07
20885380168069CARDINAL HEALTHC3660PPLC3660PPL2019-04-30
10192253045093KendallMK00175MK001752023-06-15
10192253013016Argyle888875001888887500182022-10-26
10192253013023Argyle888875051388887505132022-10-26
10198956056497CARDINAL HEALTHPN69MSGADPN69MSGAD2026-05-25
10198956057005CARDINAL HEALTHSBACGDPMEDSBACGDPMED2026-05-25
10198956221161CARDINAL HEALTHSOP29PLCCYSOP29PLCCY2026-05-25
10198956253773CARDINAL HEALTHSOP56TKTCCSOP56TKTCC2026-05-25
10198956257610CARDINAL HEALTHSOPOCTKLHKSOPOCTKLHK2026-05-25
10198956258730CARDINAL HEALTHAMN4Q8277CAMN4Q8277C2026-05-25
10198956291812CARDINAL HEALTHSOP4FKPWFBSOP4FKPWFB2026-05-25
10198956300316CARDINAL HEALTH34-2071H34-2071H2026-05-25
10198956321632CARDINAL HEALTHSOPCGKHAUCSOPCGKHAUC2026-05-25
10198956325487CARDINAL HEALTHPO43LEUNCPO43LEUNC2026-05-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
50198956323443CARDINAL HEALTHCardinal Health 200, LLCOFT2026-02-09
04046955901197Combined Spinal & EpiduralB. BRAUN MEDICAL INC.OFT2026-02-03
50198956307795CARDINAL HEALTHCardinal Health 200, LLCOFT2025-12-31
20888277722276Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFT2025-12-18
50198956184037CARDINAL HEALTHCardinal Health 200, LLCOFT2025-08-27
40198459449063MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.OFT2025-08-18
40198459453657MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.OFT2025-08-18
40198459461249MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.OFT2025-08-18
40198459461256MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.OFT2025-08-18
40198459468231MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.OFT2025-08-18
40198459472924MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.OFT2025-08-18
40198459474379MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.OFT2025-08-18
40198459474386MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.OFT2025-08-18
40198459474393MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.OFT2025-08-18
40198459474409MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.OFT2025-08-18
40198459475451MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.OFT2025-08-18
40198459475642MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.OFT2025-08-18
40198459478292MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.OFT2025-08-18
40198459478827MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.OFT2025-08-18
20809160492120Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OFT2025-08-14
40198459446062MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.OFT2025-08-11
40198459461263MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.OFT2025-08-11
40198459463878MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.OFT2025-08-11
40198459463885MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.OFT2025-08-11
40198459464448MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.OFT2025-08-11
40198459464479MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.OFT2025-08-11
40198459466244MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.OFT2025-08-11
40198459466350MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.OFT2025-08-11
40198459466411MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.OFT2025-08-11
40198459467517MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.OFT2025-08-11