FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10195594886318
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SBA11IVJR7
Catalog number
SBA11IVJR7
Device description
ESI PACK
Published
2022-10-11
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
50195594886316PackageGS115In Commercial Distribution
10195594886318PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019559488631650195594886316
1019559488631810195594886318

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.

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
10195594811242CARDINAL HEALTHCardinal Health 200, LLCOGE2022-10-10