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
20885380214377KendallCB2LCB2L2026-10-12
20885380214384KendallCB2LITECB2LITE2026-10-12
20885380214391KendallCB2XLCB2XL2026-10-12
20885380214407KendallCB3LCB3L2026-10-12
20885380214414KendallCB4LCB4L2026-10-12
10192253046397Kendall55535PAMD55535PAMD2023-09-27
10192253046762Kendall55588BAMD55588BAMD2023-10-09
10885380173691Curity6309G6309G2019-11-14
20192253039358Kerlix458845882025-03-19
20192253039365Kerlix50425042-2025-03-19
20192253039372Kerlix61206120-2025-03-19
20192253039396Kerlix507250722025-03-19
20192253039594Kerlix258525852025-03-19
20885380173490Curity2556G2556G2019-11-14
20885380173513Curity2835G2835G2019-11-14
20192253008347CARDINAL HEALTH5005005005002020-09-24
20192253016632Kendall222002A222002A-2024-02-28
20192253016830Kendall30710001307100012024-02-28
20192253017813KendallEF00149EF001492024-02-28
20885380130950MEDI-VAC65652-11965652-1192018-03-06

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