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
10192253004243Monoject31143699311436992026-08-03
10192253004250Monoject31143798311437982026-08-03
10192253004304Monoject31300878313008782026-08-03
20192253050353Vistec659165912023-05-24
10192253004458Monoject85121851212026-07-31
10192253004465Monoject8513018513012026-07-31
10192253004472Monoject85131851312026-07-31
10192253004915Monoject890689062026-07-31
10192253005066Monoject89671896712026-07-31
10192253005295Monoject8990Y8990Y2026-07-31
10192253005516Monoject8535Y8535Y2026-07-31
10192253005622Monoject8970Y8970Y2026-07-31
10197106933145CARDINAL HEALTHPV42CJTMZPV42CJTMZ2026-07-31
10197106950012CARDINAL HEALTHSAN56IPIDFSAN56IPIDF2026-07-31
10198956027596CARDINAL HEALTHSCV73CAHFHSCV73CAHFH2026-07-31
10198956327603CARDINAL HEALTH26-8545D26-8545D2026-07-31
10198956342217CARDINAL HEALTHPB15LHFCLPB15LHFCL2026-07-31
10198956352315CARDINAL HEALTHPW45KFMSAPW45KFMSA2026-07-31
10198956353961CARDINAL HEALTHSNEHBNEECDSNEHBNEECD2026-07-31
10198956364998CARDINAL HEALTHSBADHHMCFDSBADHHMCFD2026-07-31

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