FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956532250
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SMA04OBW28
Catalog number
SMA04OBW28
Device description
OB PACK
Published
2026-07-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
OKVObstetrical kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OKVObstetrical KitObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50198956532258PackageGS15In Commercial Distribution
10198956532250PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895653225850198956532258
1019895653225010198956532250

GMDN Terms#

Term, Definition table
TermDefinition
Obstetrical/gynaecological surgical procedure kit, medicatedA collection of various sterile surgical instruments, dressings, pharmaceuticals, and materials intended to be used during obstetrical/gynaecological surgery; it is a general-purpose obstetrical/gynaecological surgical kit, and as such is not dedicated to a specific procedure. This is a single-use device.

Regulatory Flags#

DUNS number
961027315
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10885380152412CARDINAL HEALTHCAX2304BACAX2304BA2017-10-12
10885380152429CARDINAL HEALTHCAX2304BDCAX2304BD2017-10-12
10885380152559CARDINAL HEALTHCAX2330LACAX2330LA2021-10-27
10885380152566CARDINAL HEALTHCAX2330LDCAX2330LD2021-10-27
10885380171109CARDINAL HEALTHCAX1230LACAX1230LA2020-06-21
10885380171116CARDINAL HEALTHCAX1230LDCAX1230LD2020-06-21
10885380171147CARDINAL HEALTHCAX3030LACAX3030LA2020-06-21
10885380171154CARDINAL HEALTHCAX3030LDCAX3030LD2020-06-21
10885380164545CARDINAL HEALTHCAX5030LACAX5030LA2020-03-18
10885380164552CARDINAL HEALTHCAX5030LDCAX5030LD2020-03-18
10198956286306CARDINAL HEALTHSOPOCLRWSHSOPOCLRWSH2026-08-26
10198956330221CARDINAL HEALTHSBA5FLCABBSBA5FLCABB2026-08-26
10198956346246CARDINAL HEALTHSCVHDVPAGCSCVHDVPAGC2026-08-26
10198956373105CARDINAL HEALTHSNE43LMSUBSNE43LMSUB2026-08-26
10198956384330CARDINAL HEALTHSMA45DCWPBSMA45DCWPB2026-08-26
10198956409767CARDINAL HEALTHSEN18EAVBOSEN18EAVBO2026-08-26
10198956417533CARDINAL HEALTHSEY13EPLHMSEY13EPLHM2026-08-26
10198956423633CARDINAL HEALTHPOCGEXBLJPOCGEXBLJ2026-08-26
10198956437746CARDINAL HEALTH38-8433D38-8433D2026-08-26
10198956461048CARDINAL HEALTHSOP18FTSTMSOP18FTSTM2026-08-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160531853HalyardAVID MEDICAL, INC.OKV2026-08-27
10809160531938HalyardAVID MEDICAL, INC.OKV2026-08-27
10809160531969HalyardAVID MEDICAL, INC.OKV2026-08-27
10809160532027HalyardAVID MEDICAL, INC.OKV2026-08-27
10809160532065HalyardAVID MEDICAL, INC.OKV2026-08-27
10809160532096HalyardAVID MEDICAL, INC.OKV2026-08-27
10809160531747HalyardAVID MEDICAL, INC.OKV2026-08-26
10809160531761HalyardAVID MEDICAL, INC.OKV2026-08-26
10809160531327HalyardAVID MEDICAL, INC.OKV2026-08-21
10809160531402HalyardAVID MEDICAL, INC.OKV2026-08-21
10809160530290HalyardAVID MEDICAL, INC.OKV2026-08-18
10809160530474HalyardAVID MEDICAL, INC.OKV2026-08-18
10809160530481HalyardAVID MEDICAL, INC.OKV2026-08-18
10809160530498HalyardAVID MEDICAL, INC.OKV2026-08-18
10809160530528HalyardAVID MEDICAL, INC.OKV2026-08-18
10809160530542HalyardAVID MEDICAL, INC.OKV2026-08-18
10809160529362HalyardAVID MEDICAL, INC.OKV2026-08-07
10809160529379HalyardAVID MEDICAL, INC.OKV2026-08-07
10809160528402HalyardAVID MEDICAL, INC.OKV2026-08-03
10809160528471HalyardAVID MEDICAL, INC.OKV2026-08-03
10198956531307CARDINAL HEALTHCardinal Health 200, LLCOKV2026-07-31
10198956534094CARDINAL HEALTHCardinal Health 200, LLCOKV2026-07-31
10198956536999CARDINAL HEALTHCardinal Health 200, LLCOKV2026-07-31
10809160528075HalyardAVID MEDICAL, INC.OKV2026-07-29
10809160527856HalyardAVID MEDICAL, INC.OKV2026-07-28
10198956499263CARDINAL HEALTHCardinal Health 200, LLCOKV2026-07-27
10198956510937CARDINAL HEALTHCardinal Health 200, LLCOKV2026-07-27
10809160527702HalyardAVID MEDICAL, INC.OKV2026-07-21
10809160527542HalyardAVID MEDICAL, INC.OKV2026-07-20
10809160527382HalyardAVID MEDICAL, INC.OKV2026-07-17