FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956530270
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
34-4132M
Catalog number
34-4132M
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
50198956530278PackageGS130In Commercial Distribution
10198956530270PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895653027850198956530278
1019895653027010198956530270

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, medicatedA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, and that includes a pharmaceutical component, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. 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
10192253015553T.E.D.399539952026-06-19
20192253016748Kendall22853228532021-05-19
20192253016755Kendall2285522855-2021-02-23
20192253017455Kendall31469219314692192021-05-05
20192253017547Medi-Trace Cadence22550A22550A-2021-07-28
20192253017554Medi-Trace Cadence22550P22550P-2021-08-19
20192253017578Medi-Trace Cadence22550PC22550PC2021-07-29
20192253017585Medi-Trace Cadence22550R22550R-2021-07-29
20192253017608Medi-Trace Cadence22660R22660R-2024-02-28
20192253017622Medi-Trace Cadence22770P22770P2021-08-19
20192253017639Medi-Trace Cadence22770PC22770PC2021-07-29
20192253017721Kendall31319281313192812021-05-05
20192253018889Medi-Trace Cadence22770R22770R-2021-07-29
20192253020240Kerlix332433242020-09-22
50192253020197Kerlix189218922020-08-12
50192253020357Kerlix673567352020-08-12
50192253020364Kerlix788278822020-08-12
50192253050422Devon31142931311429312023-07-10
20192253017592Medi-Trace Cadence22660PC22660PC2021-07-29
10198956037908CARDINAL HEALTH08-3641G08-3641G2026-09-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956542853CARDINAL HEALTHCardinal Health 200, LLCOGE2026-09-04
10198956560369CARDINAL HEALTHCardinal Health 200, LLCOGE2026-09-04
10198956561847CARDINAL HEALTHCardinal Health 200, LLCOGE2026-09-04
10198956563155CARDINAL HEALTHCardinal Health 200, LLCOGE2026-09-04
10198956564343CARDINAL HEALTHCardinal Health 200, LLCOGE2026-09-04
10198956564619CARDINAL HEALTHCardinal Health 200, LLCOGE2026-09-04
10198956565227CARDINAL HEALTHCardinal Health 200, LLCOGE2026-09-04
B098AMS198620Aligned Medical SolutionsAligned Medical SolutionsOGE2026-08-31
10198956366107CARDINAL HEALTHCardinal Health 200, LLCOGE2026-08-18
10198956551411CARDINAL HEALTHCardinal Health 200, LLCOGE2026-08-18
04046955862658Design Options®B. BRAUN MEDICAL INC.OGE2026-08-17
B098AMS19234A0Aligned Medical SolutionsAligned Medical SolutionsOGE2026-08-16
00628725050218Clint Pharmaceuticals SINGLE SHOT EPIDURAL TRAYCHS USA Inc.OGE2026-08-07
00628725050225Clint Pharmaceuticals SINGLE SHOT EPIDURAL TRAYCHS USA Inc.OGE2026-08-07
00628725050317Clint Pharmaceuticals SINGLE SHOT EPIDURAL TRAYCHS USA Inc.OGE2026-08-07
00628725050348Clint Pharmaceuticals SINGLE SHOT EPIDURAL TRAYCHS USA Inc.OGE2026-08-07
00628725050386Clint Pharmaceuticals SINGLE SHOT EPIDURAL TRAYCHS USA Inc.OGE2026-08-07
10198956533097CARDINAL HEALTHCardinal Health 200, LLCOGE2026-07-31
10198956516847CARDINAL HEALTHCardinal Health 200, LLCOGE2026-07-27
10198956530218CARDINAL HEALTHCardinal Health 200, LLCOGE2026-07-27
10198956531253CARDINAL 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