FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10197106398050
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
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

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
20885380173544Curity9022G9022G2019-11-14
20885380173568Curity9024G9024G2019-11-14
10198956038127CARDINAL HEALTHSAN22IAMRASAN22IAMRA2026-10-19
10198956180000CARDINAL HEALTHPUV2KPMHBPUV2KPMHB2026-10-19
10198956268111CARDINAL HEALTHSNECGACSGESNECGACSGE2026-10-19
10198956377967CARDINAL HEALTHSBA56MIMCFSBA56MIMCF2026-10-19
10198956384774CARDINAL HEALTHSVA42LVGLCSVA42LVGLC2026-10-19
10198956390799CARDINAL HEALTHSEYCGEPAZBSEYCGEPAZB2026-10-19
10198956400795CARDINAL HEALTHSOP3MKPCVDSOP3MKPCVD2026-10-19
10198956414815CARDINAL HEALTHSMA41PGEPBSMA41PGEPB2026-10-19
10198956441811CARDINAL HEALTHSCV29VPPCUSCV29VPPCU2026-10-19
10198956462328CARDINAL HEALTHSCV13PPBTESCV13PPBTE2026-10-19
10198956464988CARDINAL HEALTHSOP51XRKKPSOP51XRKKP2026-10-19
10198956499270CARDINAL HEALTHPG33BGMKBPG33BGMKB2026-10-19
10198956499980CARDINAL HEALTH33-2528E33-2528E2026-10-19
10198956506732CARDINAL HEALTHSOP41TPDSFSOP41TPDSF2026-10-19
10198956513587CARDINAL HEALTHSAN33CACHNSAN33CACHN2026-10-19
10198956514874CARDINAL HEALTHSOPOCTKSBBSOPOCTKSBB2026-10-19
10198956516922CARDINAL HEALTHPC23TAAMEPC23TAAME2026-10-19
10198956518964CARDINAL HEALTHSAN40CCAEGSAN40CCAEG2026-10-19

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
50197106398058CARDINAL 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