FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50198956068702
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SMA13OBBK2
Catalog number
SMA13OBBK2
Device description
OB PACK ASTOUND PACK
Published
2025-05-12
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
50198956068702PackageGS16In Commercial Distribution
10198956068704PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895606870250198956068702
1019895606870410198956068704

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.

Sterilization Methods#

Method table
Method

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
10192253047967Kendall92339233-2026-05-26
20192253017615Medi-Trace Cadence22661PC22661PC2021-07-29
20192253019992Kendall33547T33547T--2026-05-26
20885380136617CARDINAL HEALTHN8830N88302019-02-07
20885380136624CARDINAL HEALTHN8831N88312019-02-07
20885380136631CARDINAL HEALTHN8832N88322019-02-07
20885380168069CARDINAL HEALTHC3660PPLC3660PPL2019-04-30
10192253045093KendallMK00175MK001752023-06-15
10192253013016Argyle888875001888887500182022-10-26
10192253013023Argyle888875051388887505132022-10-26
10198956056497CARDINAL HEALTHPN69MSGADPN69MSGAD2026-05-25
10198956057005CARDINAL HEALTHSBACGDPMEDSBACGDPMED2026-05-25
10198956221161CARDINAL HEALTHSOP29PLCCYSOP29PLCCY2026-05-25
10198956253773CARDINAL HEALTHSOP56TKTCCSOP56TKTCC2026-05-25
10198956257610CARDINAL HEALTHSOPOCTKLHKSOPOCTKLHK2026-05-25
10198956258730CARDINAL HEALTHAMN4Q8277CAMN4Q8277C2026-05-25
10198956291812CARDINAL HEALTHSOP4FKPWFBSOP4FKPWFB2026-05-25
10198956300316CARDINAL HEALTH34-2071H34-2071H2026-05-25
10198956321632CARDINAL HEALTHSOPCGKHAUCSOPCGKHAUC2026-05-25
10198956325487CARDINAL HEALTHPO43LEUNCPO43LEUNC2026-05-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956441880CARDINAL HEALTHCardinal Health 200, LLCOKV2026-05-25
10198956482388CARDINAL HEALTHCardinal Health 200, LLCOKV2026-05-25
50198956426854CARDINAL HEALTHCardinal Health 200, LLCOKV2026-03-24
50198956358407CARDINAL HEALTHCardinal Health 200, LLCOKV2026-03-23
50198956396638CARDINAL HEALTHCardinal Health 200, LLCOKV2026-03-23
50198956424461CARDINAL HEALTHCardinal Health 200, LLCOKV2026-03-23
50198956424720CARDINAL HEALTHCardinal Health 200, LLCOKV2026-03-23
50198956425482CARDINAL HEALTHCardinal Health 200, LLCOKV2026-03-23
20809160517168HalyardAVID MEDICAL, INC.OKV2026-03-23
20809160517199HalyardAVID MEDICAL, INC.OKV2026-03-23
20809160516758HalyardAVID MEDICAL, INC.OKV2026-03-20
20809160516765HalyardAVID MEDICAL, INC.OKV2026-03-20
20809160516772HalyardAVID MEDICAL, INC.OKV2026-03-20
20809160516826HalyardAVID MEDICAL, INC.OKV2026-03-20
20809160516963HalyardAVID MEDICAL, INC.OKV2026-03-20
20809160516970HalyardAVID MEDICAL, INC.OKV2026-03-20
20809160517021HalyardAVID MEDICAL, INC.OKV2026-03-20
20809160517083HalyardAVID MEDICAL, INC.OKV2026-03-20
20809160516697HalyardAVID MEDICAL, INC.OKV2026-03-19
20809160516703HalyardAVID MEDICAL, INC.OKV2026-03-19
50198956329889CARDINAL HEALTHCardinal Health 200, LLCOKV2026-03-16
20809160516222HalyardAVID MEDICAL, INC.OKV2026-03-16
20809160516260HalyardAVID MEDICAL, INC.OKV2026-03-16
20809160516277HalyardAVID MEDICAL, INC.OKV2026-03-16
20809160515966HalyardAVID MEDICAL, INC.OKV2026-03-12
50198956363043CARDINAL HEALTHCardinal Health 200, LLCOKV2026-03-10
50198956393316CARDINAL HEALTHCardinal Health 200, LLCOKV2026-03-10
50198956411010CARDINAL HEALTHCardinal Health 200, LLCOKV2026-03-10
50198956405910CARDINAL HEALTHCardinal Health 200, LLCOKV2026-03-09
20809160515270HalyardAVID MEDICAL, INC.OKV2026-03-09