FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50197106488858
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
34-2477G
Catalog number
34-2477G
Device description
INJECTION TRAY
Published
2023-12-22
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
OFQAnesthesia kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OFQAnesthesia KitAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50197106488858PackageGS118In Commercial Distribution
10197106488850PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710648885850197106488858
1019710648885010197106488850

GMDN Terms#

Term, Definition table
TermDefinition
Epidural anaesthesia set, medicatedA collection of devices intended for the administration of an analgesic or anaesthetic agent to the epidural space for the management of pain. It includes the pharmaceutical anaesthetic agent and a needle, with additional devices utilized for the procedure (e.g., syringe, dressings), and may include a catheter (i.e., may be intended for single- or continuous-administration). It is not intended for intrathetcal 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
10198956472716CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-05-25
10198956482227CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-05-25
50198956315998CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-03-23
50198956318999CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-03-23
50198956323108CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-03-23
50198956343366CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-03-23
50198956379815CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-03-23
50198956382235CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-03-23
50198956382396CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-03-23
50198956409666CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-03-23
50198956425321CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-03-23
50198956220704CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-03-19
50198956316797CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-03-19
50198956331844CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-03-19
50198956258530CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-03-16
50198956377828CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-03-16
50198956385007CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-03-16
50198956400977CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-03-16
50198956285451CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-03-10
50198956369854CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-03-10
50198956390650CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-03-10
50198956329582CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-03-09
50198956343113CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-03-09
50198956348941CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-03-09
50198956359787CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-03-09
50198956395365CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-03-09
50198956350104CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-03-06
50198956364866CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-03-06
50198956369380CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-03-06
50198956390933CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-03-06