FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956516847
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
34-0822A
Catalog number
34-0822A
Device description
ELKIN ESI KIT
Published
2026-07-27
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
50198956516845PackageGS116In Commercial Distribution
10198956516847PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895651684550198956516845
1019895651684710198956516847

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 Temperature00

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
00885380173700Curity1806G1806G2026-10-26
10192253010015Kangaroo7761507761502026-10-26
10198956294127CARDINAL HEALTHSOPHDTHWWCSOPHDTHWWC2026-10-26
10198956515376CARDINAL HEALTHSBA69FFKWRSBA69FFKWR2026-10-26
10198956516342CARDINAL HEALTHSMA54GLPOISMA54GLPOI2026-10-26
10198956519138CARDINAL HEALTHSMA55CPYKFSMA55CPYKF2026-10-26
10198956542006CARDINAL HEALTH20-485AI20-485AI2026-10-26
10198956555839CARDINAL HEALTHAMN696315EAMN696315E2026-10-26
10198956562905CARDINAL HEALTHSEY57KC00GSEY57KC00G2026-10-26
10198956565784CARDINAL HEALTHSNEOCSPSBCSNEOCSPSBC2026-10-26
10198956566705CARDINAL HEALTHPN41LMLAKPN41LMLAK2026-10-26
10198956568884CARDINAL HEALTH27-9143M27-9143M2026-10-26
10198956573437CARDINAL HEALTHSAN12AIUVFSAN12AIUVF2026-10-26
10198956575028CARDINAL HEALTHSMA73UGKSISMA73UGKSI2026-10-26
10198956576940CARDINAL HEALTHSOP69SH45CSOP69SH45C2026-10-26
10198956577107CARDINAL HEALTHSEN4AEAJHWSEN4AEAJHW2026-10-26
10198956577282CARDINAL HEALTHSBAOCMBKCRSBAOCMBKCR2026-10-26
10198956578869CARDINAL HEALTHSBAOCMJWYJSBAOCMJWYJ2026-10-26
10198956590359CARDINAL HEALTHSBA4QFLFPCSBA4QFLFPC2026-10-26
10198956591981CARDINAL HEALTHSOP69EEKRESOP69EEKRE2026-10-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956614451CARDINAL HEALTHCardinal Health 200, LLCOGE2026-10-26
10198956560543CARDINAL HEALTHCardinal Health 200, LLCOGE2026-10-23
10198956569430CARDINAL HEALTHCardinal Health 200, LLCOGE2026-10-23
10198956595361CARDINAL HEALTHCardinal Health 200, LLCOGE2026-10-23
10198956613102CARDINAL HEALTHCardinal Health 200, LLCOGE2026-10-23
10198956576131CARDINAL HEALTHCardinal Health 200, LLCOGE2026-10-19
10198956607644CARDINAL HEALTHCardinal Health 200, LLCOGE2026-10-19
04046955966295Design Options®B. BRAUN MEDICAL INC.OGE2026-10-18
10198956563056CARDINAL HEALTHCardinal Health 200, LLCOGE2026-10-15
10198956568969CARDINAL HEALTHCardinal Health 200, LLCOGE2026-10-15
10198956604650CARDINAL HEALTHCardinal Health 200, LLCOGE2026-10-15
10198956604902CARDINAL HEALTHCardinal Health 200, LLCOGE2026-10-15
10198956578753CARDINAL HEALTHCardinal Health 200, LLCOGE2026-10-13
10198956545274CARDINAL HEALTHCardinal Health 200, LLCOGE2026-10-12
10198956589827CARDINAL HEALTHCardinal Health 200, LLCOGE2026-10-12
10198956579866CARDINAL HEALTHCardinal Health 200, LLCOGE2026-10-06
10198956588844CARDINAL HEALTHCardinal Health 200, LLCOGE2026-10-06
10198956563087CARDINAL HEALTHCardinal Health 200, LLCOGE2026-10-01
10198956580138CARDINAL HEALTHCardinal Health 200, LLCOGE2026-09-30
10198956545946CARDINAL HEALTHCardinal Health 200, LLCOGE2026-09-29
10198956566910CARDINAL HEALTHCardinal Health 200, LLCOGE2026-09-29
10198956569386CARDINAL HEALTHCardinal Health 200, LLCOGE2026-09-29
10198956575615CARDINAL HEALTHCardinal Health 200, LLCOGE2026-09-29
B098AMS195170Aligned Medical SolutionsAligned Medical SolutionsOGE2026-09-26
10198956565982CARDINAL HEALTHCardinal Health 200, LLCOGE2026-09-25
10198956586543CARDINAL HEALTHCardinal Health 200, LLCOGE2026-09-25
10198956590724CARDINAL HEALTHCardinal Health 200, LLCOGE2026-09-25
10198956550377CARDINAL HEALTHCardinal Health 200, LLCOGE2026-09-21
10198956542853CARDINAL HEALTHCardinal Health 200, LLCOGE2026-09-04
10198956560369CARDINAL HEALTHCardinal Health 200, LLCOGE2026-09-04