FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956531253
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
34-6416L
Catalog number
34-6416L
Device description
SINGLE SHOT EPIDURAL TRAY
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
50198956531251PackageGS130In Commercial Distribution
10198956531253PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895653125150198956531251
1019895653125310198956531253

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
10192253072037CARDINAL HEALTHALMASK5ALMASK52026-07-29
10192253072044CARDINAL HEALTHAMMASK4AMMASK42026-07-29
10192253072051CARDINAL HEALTHAXLMASK6AXLMASK62026-07-29
10192253072068CARDINAL HEALTHCHIMASK3CHIMASK32026-07-29
10192253072075CARDINAL HEALTHINFMASK1INFMASK12026-07-29
10192253072082CARDINAL HEALTHNEOMASK0NEOMASK02026-07-29
10192253072105CARDINAL HEALTHTODMASK2TODMASK22026-07-29
10192253025699Dover888876051688887605162023-11-21
10192253025705Dover888876051888887605182023-11-21
10192253025712Dover888876052088887605202023-11-21
10192253025750Dover888876301888887630182023-11-21
10192253025774Dover888876302288887630222023-11-21
10192253026344Dover35603560-2022-04-12
10192253028201Dover62086208-2024-10-14
10192253030365Dover888849206688884920662025-04-07
10192253031836DoverP4P16ULDP4P16ULD-2024-08-22
10192253068573Dover33053305-2026-01-16
10192253068634Dover61556155-2026-01-16
10197106541029CARDINAL HEALTH01A1360C01A1360C2024-03-06
10197106741030CARDINAL HEALTH03-2242D03-2242D2024-09-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956516847CARDINAL HEALTHCardinal Health 200, LLCOGE2026-07-27
10198956530218CARDINAL HEALTHCardinal Health 200, LLCOGE2026-07-27
10198956530270CARDINAL HEALTHCardinal Health 200, LLCOGE2026-07-27
10198956531482CARDINAL HEALTHCardinal Health 200, LLCOGE2026-07-27
10198956533110CARDINAL HEALTHCardinal Health 200, LLCOGE2026-07-27
04046955966288Design Options®B. BRAUN MEDICAL INC.OGE2026-07-26
00628725050416Epidural Anesthesia Kit Clint PharmaceuticalsCHS USA Inc.OGE2026-07-21
00628725050300Epidural Anesthesia Kit Clint PharmaceuticalsCHS USA Inc.OGE2026-07-20
00628725050331Epidural Anesthesia Kit Clint PharmaceuticalsCHS USA Inc.OGE2026-07-20
00628725050362Epidural Anesthesia Kit Clint PharmaceuticalsCHS USA Inc.OGE2026-07-20
00628725050379Epidural Anesthesia Kit Clint PharmaceuticalsCHS USA Inc.OGE2026-07-20
00628725050409Epidural Anesthesia Kit Clint PharmaceuticalsCHS USA Inc.OGE2026-07-20
00628725050423Epidural Anesthesia Kit Clint PharmaceuticalsCHS USA Inc.OGE2026-07-20
10198956522015CARDINAL HEALTHCardinal Health 200, LLCOGE2026-07-20
B098AMS11096B0Aligned Medical SolutionsAligned Medical SolutionsOGE2026-07-19
B098AMS188250Aligned Medical SolutionsAligned Medical SolutionsOGE2026-07-19
00628725050232Epidural Anesthesia Kit Clint PharmaceuticalsCHS USA Inc.OGE2026-07-17
00628725050249Epidural Anesthesia Kit Clint PharmaceuticalsCHS USA Inc.OGE2026-07-17
00628725050256Epidural Anesthesia Kit Clint PharmaceuticalsCHS USA Inc.OGE2026-07-17
00628725050270Epidural Anesthesia Kit Clint PharmaceuticalsCHS USA Inc.OGE2026-07-17
00628725050324Epidural Anesthesia KitCHS USA Inc.OGE2026-07-17
B098AMS12381C0Aligned Medical SolutionsAligned Medical SolutionsOGE2026-07-12
10198956460003CARDINAL HEALTHCardinal Health 200, LLCOGE2026-07-09
10198956458529CARDINAL HEALTHCardinal Health 200, LLCOGE2026-07-06
10198956518698CARDINAL HEALTHCardinal Health 200, LLCOGE2026-07-06
B098AMS10930A0Aligned Medical SolutionsAligned Medical SolutionsOGE2026-07-03
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