FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10195594811242
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
34-3517A
Catalog number
34-3517A
Device description
ST CROIX EPIDURAL TRAY
Published
2022-10-10
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
50195594811240PackageGS124In Commercial Distribution
10195594811242PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019559481124050195594811240
1019559481124210195594811242

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

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
10192253047981Kendall923692362026-06-09
10192253047998Kendall923892382026-06-09
10192253048001Kendall923992392026-06-09
10192253048018Kendall924092402026-06-09
10192253048025Kendall924292422026-06-09
10192253048032Kendall924392432026-06-09
10192253046205Webcol511051102024-09-05
10192253047066Webcol68186818-2025-06-10
10192253047073Webcol6818-16818-12025-07-28
10884521008427Dover502750272016-09-24
10885380052538CARDINAL HEALTHC-CB2SC-CB2S2023-08-07
10885380052545CARDINAL HEALTHC-CB3SC-CB3S2023-08-07
10885380052569CARDINAL HEALTHC-CB6SC-CB6S2023-08-07
10885380052613CARDINAL HEALTHC-CB6C-CB62023-08-07
10885380107801CARDINAL HEALTHABP1201ABP12012016-07-22
10885380107818CARDINAL HEALTHASC1201ASC12012016-07-22
10885380107825CARDINAL HEALTHASC1210ASC12102016-07-22
10885380107832CARDINAL HEALTHASC1211ASC12112016-07-22
10885380107849CARDINAL HEALTHASC1220ASC12202016-07-22
10885380107856CARDINAL HEALTHASC1221ASC12212016-07-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
10197106012888CARDINAL HEALTHCardinal Health 200, LLCOGE2023-07-12
10193489431926Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGE2023-06-08
10195594691356CARDINAL HEALTHCardinal Health 200, LLCOGE2023-04-04
10195594804459CARDINAL HEALTHCardinal Health 200, LLCOGE2023-01-25
10195594890018CARDINAL HEALTHCardinal Health 200, LLCOGE2023-01-19
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
10197106016015CARDINAL HEALTHCardinal Health 200, LLCOGE2022-11-10
10197106010365CARDINAL HEALTHCardinal Health 200, LLCOGE2022-11-04
10197106010464CARDINAL 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