FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50197106633838
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
34-7281F
Catalog number
34-7281F
Device description
EPIDURAL TRAY
Published
2024-07-08
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
OGEEpidural anesthesia kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OGEEpidural Anesthesia KitAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50197106633838PackageGS140In Commercial Distribution
10197106633830PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710663383850197106633838
1019710663383010197106633830

GMDN Terms#

Term, Definition table
TermDefinition
Epidural/intrathecal anaesthesia set, non-medicatedA dual-purpose collection of devices intended for the administration of an analgesic or anaesthetic agent (not included) to the intrathecal space and to the epidural space for the management of pain. It includes both a spinal needle and an epidural needle with additional devices utilized for the procedure (e.g., dressings, syringe) and may include an epidural catheter for continuous-administration. This is a single-use device.

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
50198956284980CARDINAL HEALTHCardinal Health 200, LLCOGE2026-03-24
50198956385854CARDINAL HEALTHCardinal Health 200, LLCOGE2026-03-23
50198956413748CARDINAL HEALTHCardinal Health 200, LLCOGE2026-03-23
50198956413908CARDINAL HEALTHCardinal Health 200, LLCOGE2026-03-23
50198956290837CARDINAL HEALTHCardinal Health 200, LLCOGE2026-03-16
50198956369823CARDINAL HEALTHCardinal Health 200, LLCOGE2026-03-10
50198956382464CARDINAL HEALTHCardinal Health 200, LLCOGE2026-03-10
50198956393590CARDINAL HEALTHCardinal Health 200, LLCOGE2026-03-09
50198956378375CARDINAL HEALTHCardinal Health 200, LLCOGE2026-03-03
50198956347623CARDINAL HEALTHCardinal Health 200, LLCOGE2026-03-02
50198956391107CARDINAL HEALTHCardinal Health 200, LLCOGE2026-03-02
50198956329704CARDINAL HEALTHCardinal Health 200, LLCOGE2026-02-23
50198956338645CARDINAL HEALTHCardinal Health 200, LLCOGE2026-02-23
50198956341010CARDINAL HEALTHCardinal Health 200, LLCOGE2026-02-23
50198956341157CARDINAL HEALTHCardinal Health 200, LLCOGE2026-02-23
50198956293906CARDINAL HEALTHCardinal Health 200, LLCOGE2026-02-13
50198956365597CARDINAL HEALTHCardinal Health 200, LLCOGE2026-02-13
50198956298024CARDINAL HEALTHCardinal Health 200, LLCOGE2026-02-09
50198956315981CARDINAL HEALTHCardinal Health 200, LLCOGE2026-02-09
50198956358056CARDINAL HEALTHCardinal Health 200, LLCOGE2026-02-09
04045928020866Design Options®B. BRAUN MEDICAL INC.OGE2026-02-03
04046955900534Perifix®B. BRAUN MEDICAL INC.OGE2026-02-03
04046955900855Design Options®B. BRAUN MEDICAL INC.OGE2026-02-03
50198956318340CARDINAL HEALTHCardinal Health 200, LLCOGE2026-01-26
50198956303902CARDINAL HEALTHCardinal Health 200, LLCOGE2026-01-23
50198956317152CARDINAL HEALTHCardinal Health 200, LLCOGE2026-01-22
50198956299144CARDINAL HEALTHCardinal Health 200, LLCOGE2026-01-15
00191072241689ACSAMERICAN CONTRACT SYSTEMS, INC.OGE2026-01-14
50198956180275CARDINAL HEALTHCardinal Health 200, LLCOGE2026-01-13
50198956316230CARDINAL HEALTHCardinal Health 200, LLCOGE2026-01-13