FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10195594894368
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SMA12DCGT7
Catalog number
SMA12DCGT7
Device description
LD DC
Published
2022-10-19
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
50195594894366PackageGS17In Commercial Distribution
10195594894368PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019559489436650195594894366
1019559489436810195594894368

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
10198956101524CARDINAL HEALTHSOP73TKAPBSOP73TKAPB2026-06-03
10198956177055CARDINAL HEALTHPBCGPVWTIPBCGPVWTI2026-06-03
10198956198456CARDINAL HEALTHSMA69OMBFFSMA69OMBFF2026-06-03
10198956309012CARDINAL HEALTHMAT534227DMAT534227D2026-06-03
10198956320086CARDINAL HEALTHSOP73HESJESOP73HESJE2026-06-03
10198956320123CARDINAL HEALTHPV63ADSTIPV63ADSTI2026-06-03
10198956328938CARDINAL HEALTHSCV3ICVJCDSCV3ICVJCD2026-06-03
10198956332638CARDINAL HEALTHSOP52AC52ASOP52AC52A2026-06-03
10198956334915CARDINAL HEALTHSANCGCARIFSANCGCARIF2026-06-03
10198956346369CARDINAL HEALTHSCVCGEPSBBSCVCGEPSBB2026-06-03
10198956348950CARDINAL HEALTHSBA4LMNGRESBA4LMNGRE2026-06-03
10198956362147CARDINAL HEALTHSOP73KPIODSOP73KPIOD2026-06-03
10198956363922CARDINAL HEALTHSEN41FPVVDSEN41FPVVD2026-06-03
10198956371040CARDINAL HEALTHSOP56KAOSHSOP56KAOSH2026-06-03
10198956372641CARDINAL HEALTHSOP43ARANBSOP43ARANB2026-06-03
10198956379008CARDINAL HEALTHSOP45CAGHISOP45CAGHI2026-06-03
10198956385689CARDINAL HEALTHSOP44TKSVCSOP44TKSVC2026-06-03
10198956386099CARDINAL HEALTHSMA56IVRCBSMA56IVRCB2026-06-03
10198956390928CARDINAL HEALTHSBA54LCTCCSBA54LCTCC2026-06-03
10198956391437CARDINAL HEALTHSOT42SPMSESOT42SPMSE2026-06-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10197106547625CARDINAL HEALTHCardinal Health 200, LLCOKC2024-02-26
50197106547623CARDINAL HEALTHCardinal Health 200, LLCOKC2024-02-26
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