FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956454101
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SMA43OBABB
Catalog number
SMA43OBABB
Device description
OB PACK
Published
2026-06-08
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
50198956454109PackageGS14In Commercial Distribution
10198956454101PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895645410950198956454109
1019895645410110198956454101

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature00

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
10197106911266CARDINAL HEALTHSBA60POLHCSBA60POLHC2026-06-08
10197106983577CARDINAL HEALTHSEN69ERMVDSEN69ERMVD2026-06-08
10198956182264CARDINAL HEALTHSCV43OOTGKSCV43OOTGK2026-06-08
10198956218611CARDINAL HEALTHSOP55AOKFJSOP55AOKFJ2026-06-08
10198956227552CARDINAL HEALTHSEY33EPCAFSEY33EPCAF2026-06-08
10198956279391CARDINAL HEALTH01-0111A01-0111A2026-06-08
10198956312920CARDINAL HEALTHSMA57CESARSMA57CESAR2026-06-08
10198956332096CARDINAL HEALTHSOP32THGMLSOP32THGML2026-06-08
10198956336865CARDINAL HEALTHPN73CRKPBPN73CRKPB2026-06-08
10198956343139CARDINAL HEALTHSOP45HAOCCSOP45HAOCC2026-06-08
10198956359024CARDINAL HEALTHSBA24UPJRGSBA24UPJRG2026-06-08
10198956362932CARDINAL HEALTHSEN48TASABSEN48TASAB2026-06-08
10198956364349CARDINAL HEALTHSBACGRPGRASBACGRPGRA2026-06-08
10198956364783CARDINAL HEALTHSNE38LMCIBSNE38LMCIB2026-06-08
10198956373372CARDINAL HEALTHSOP31EXHNGSOP31EXHNG2026-06-08
10198956373976CARDINAL HEALTHSOP38SHUSHSOP38SHUSH2026-06-08
10198956374119CARDINAL HEALTHSBA56LPSTCSBA56LPSTC2026-06-08
10198956386150CARDINAL HEALTHSEN69SPREBSEN69SPREB2026-06-08
10198956387171CARDINAL HEALTHSBA41PLRSESBA41PLRSE2026-06-08
10198956390430CARDINAL HEALTHSEN37TSPSDSEN37TSPSD2026-06-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160522837HalyardAVID MEDICAL, INC.OKV2026-06-08
10809160522851HalyardAVID MEDICAL, INC.OKV2026-06-08
10809160522868HalyardAVID MEDICAL, INC.OKV2026-06-08
10809160522882HalyardAVID MEDICAL, INC.OKV2026-06-08
10809160522974HalyardAVID MEDICAL, INC.OKV2026-06-08
10809160522998HalyardAVID MEDICAL, INC.OKV2026-06-08
10198956445000CARDINAL HEALTHCardinal Health 200, LLCOKV2026-06-05
10809160522776HalyardAVID MEDICAL, INC.OKV2026-06-05
10809160522424HalyardAVID MEDICAL, INC.OKV2026-06-02
10809160522431HalyardAVID MEDICAL, INC.OKV2026-06-02
10198956488229CARDINAL HEALTHCardinal Health 200, LLCOKV2026-06-01
10809160522165HalyardAVID MEDICAL, INC.OKV2026-06-01
10809160522257HalyardAVID MEDICAL, INC.OKV2026-06-01
10809160522141HalyardAVID MEDICAL, INC.OKV2026-05-29
10809160521915HalyardAVID MEDICAL, INC.OKV2026-05-27
10193489991543Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2023-10-15
10193489214284Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2023-06-08
10193489215823Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2023-06-08
10193489410211Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2023-06-08
10193489412475Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2023-06-08
10193489413014Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2023-06-08
10193489413809Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2023-06-08
10193489413984Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2023-06-08
10193489419931Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2023-06-08
10193489421637Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2023-06-08
10193489424218Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2023-06-08
10193489425758Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2023-06-08
10193489426694Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2023-06-08
10193489427516Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2023-06-08
10193489428605Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2023-06-08