FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50197106398058
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
34-4536C
Catalog number
34-4536C
Device description
EPIDURAL TRAY
Published
2023-11-09
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
OEGAutoantibodies, skin (bullous pemphigoid 180 and bullous pemphigoid 230

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OEGAutoantibodies, Skin (Bullous Pemphigoid 180 And Bullous Pemphigoid 230Immunology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50197106398058PackageGS137In Commercial Distribution
10197106398050PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710639805850197106398058
1019710639805010197106398050

GMDN Terms#

Term, Definition table
TermDefinition
Epidural/intrathecal anaesthesia set, medicatedA dual-purpose collection of devices intended for the administration of an analgesic or anaesthetic agent to the intrathecal space and to the epidural space for the management of pain. It includes the pharmaceutical anaesthetic agent, and both a spinal needle and an epidural needle with additional devices utilized for the procedure (e.g., dressings, syringe), and may include an epidural catheter for continuous-administration. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature040 Degrees Celsius

Sterilization Methods#

Method table
Method

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
10198956232792CARDINAL HEALTHSOP3IOLUTASOP3IOLUTA2026-07-16
10198956260016CARDINAL HEALTHSNE23SPMABSNE23SPMAB2026-07-16
10198956319929CARDINAL HEALTHSAN55TPKFCSAN55TPKFC2026-07-16
10198956326484CARDINAL HEALTH03-1708O03-1708O2026-07-16
10198956334342CARDINAL HEALTHPO21FKEGBPO21FKEGB2026-07-16
10198956335523CARDINAL HEALTHSAN19CCKHOSAN19CCKHO2026-07-16
10198956344020CARDINAL HEALTHSCV73OPBHCSCV73OPBHC2026-07-16
10198956359611CARDINAL HEALTHPO24ARSMCPO24ARSMC2026-07-16
10198956360112CARDINAL HEALTHSMA55DPKCSSMA55DPKCS2026-07-16
10198956364837CARDINAL HEALTHPO54KTGCCPO54KTGCC2026-07-16
10198956368002CARDINAL HEALTHSOPHDUPUBDSOPHDUPUBD2026-07-16
10198956382381CARDINAL HEALTHSCV5DPPUMDSCV5DPPUMD2026-07-16
10198956382930CARDINAL HEALTHSEY48CPOELSEY48CPOEL2026-07-16
10198956388178CARDINAL HEALTHSENHDTAHGDSENHDTAHGD2026-07-16
10198956390546CARDINAL HEALTHSEYHDEYSPBSEYHDEYSPB2026-07-16
10198956392755CARDINAL HEALTHSOPOCPPAEBSOPOCPPAEB2026-07-16
10198956395886CARDINAL HEALTHSAN53EPVSFSAN53EPVSF2026-07-16
10198956400856CARDINAL HEALTH08-0077C08-0077C2026-07-16
10198956408401CARDINAL HEALTHSOPVXEXBMESOPVXEXBME2026-07-16
10198956418431CARDINAL HEALTHSAN69BPKIBSAN69BPKIB2026-07-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10197106496145CARDINAL HEALTHCardinal Health 200, LLCOEG2023-12-08
50197106496143CARDINAL HEALTHCardinal Health 200, LLCOEG2023-12-08
10197106398050CARDINAL HEALTHCardinal Health 200, LLCOEG2023-11-09
04049016091608Anti-BP230-CF ELISA (IgG)EUROIMMUN Medizinische Labordiagnostika AGOEG2020-09-28
04987506015959MESACUP BP180 ELISA KitMEDICAL & BIOLOGICAL LABORATORIES CO., LTD.OEG2020-02-17
04987506015966MESACUP BP230 ELISA KitMEDICAL & BIOLOGICAL LABORATORIES CO., LTD.OEG2020-02-17
04049016026839Anti-BP180-NC16A-4X ELISA (IgG)EUROIMMUN Medizinische Labordiagnostika AGOEG2016-09-24
B110RGM7612D0BP 180 ELISA TESTBion Enterprises, Ltd.OEG2016-09-12
B110RGM7613D0BP 230 ELISA TESTBion Enterprises, Ltd.OEG2016-09-12