FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10197106547625
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SMA48OBMCA
Catalog number
SMA48OBMCA
Device description
OB PACK
Published
2024-02-26
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
OKCimplanted subcutaneous securement catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OKCImplanted Subcutaneous Securement CatheterGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50197106547623PackageGS14In Commercial Distribution
10197106547625PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710654762350197106547623
1019710654762510197106547625

GMDN Terms#

Term, Definition table
TermDefinition
Obstetrical/gynaecological surgical procedure kit, non-medicated, single-useA collection of various sterile surgical instruments, dressings/drapes, and materials intended to be used during obstetrical/gynaecological surgery. The kit may be referred to as a procedure pack and is typically comprised of devices that individually are not dedicated to a specific type of obstetrical/gynaecological surgical procedure, but are often supplied together to perform a specific type of obstetrical/gynaecological procedure; it does not contain pharmaceuticals. This is a single-use device.

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
50192253071595CONVERTORS8184NA8184NA2026-06-02
50192253071601CONVERTORS8187N8187N2026-06-02
50192253071618CONVERTORS8188NC8188NC2026-06-02
50192253071625CONVERTORS8189N8189N2026-06-02
20192253005971CONVERTORSAT7004AT70042019-04-16
20192253017080Kendall31.3876.0431.3876.042023-03-16
50885380183001CARDINAL HEALTH50001218500012182023-08-11
50885380182998CARDINAL HEALTH50001217500012172023-08-11
10197106817643CARDINAL HEALTHSEYHBDPANBSEYHBDPANB2026-06-01
10198956004887CARDINAL HEALTHSBAHFRPASCSBAHFRPASC2026-06-01
10198956201804CARDINAL HEALTH32-0828C32-0828C2026-06-01
10198956209220CARDINAL HEALTHPG33GLVWBPG33GLVWB2026-06-01
10198956225992CARDINAL HEALTHSOP54PPUOBSOP54PPUOB2026-06-01
10198956245754CARDINAL HEALTHSBACGKTACFSBACGKTACF2026-06-01
10198956248908CARDINAL HEALTHSAN43CATOBSAN43CATOB2026-06-01
10198956269323CARDINAL HEALTHSOP4QSHCLBSOP4QSHCLB2026-06-01
10198956311282CARDINAL HEALTHSCV11VSJKJSCV11VSJKJ2026-06-01
10198956312043CARDINAL HEALTHPW30PSPRHPW30PSPRH2026-06-01
10198956314634CARDINAL HEALTHSBAMIFPACBSBAMIFPACB2026-06-01
10198956314894CARDINAL HEALTHSEN42HNAMDSEN42HNAMD2026-06-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
50197106547623CARDINAL HEALTHCardinal Health 200, LLCOKC2024-02-26
10195594894368CARDINAL HEALTHCardinal Health 200, LLCOKC2022-10-19
50195594894366CARDINAL HEALTHCardinal Health 200, LLCOKC2022-10-19
00865382000280SecurAcathINTERRAD MEDICAL, INCOKC2020-06-03
00865382000297SecurAcathINTERRAD MEDICAL, INCOKC2020-06-03
00865382000204SecurAcathINTERRAD MEDICAL, INCOKC2016-09-15
00865382000211SecurAcathINTERRAD MEDICAL, INCOKC2016-09-15
00865382000228SecurAcathINTERRAD MEDICAL, INCOKC2016-09-15
00865382000235SecurAcathINTERRAD MEDICAL, INCOKC2016-09-15
00865382000242SecurAcathINTERRAD MEDICAL, INCOKC2016-09-15
00865382000259SecurAcathINTERRAD MEDICAL, INCOKC2016-09-15
10865382000201SecurAcathINTERRAD MEDICAL, INCOKC2016-09-15
10865382000218SecurAcathINTERRAD MEDICAL, INCOKC2016-09-15
10865382000232SecurAcathINTERRAD MEDICAL, INCOKC2016-09-15
10865382000249SecurAcathINTERRAD MEDICAL, INCOKC2016-09-15
10865382000256SecurAcathINTERRAD MEDICAL, INCOKC2016-09-15