FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956571891
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SMA14OBK10
Catalog number
SMA14OBK10
Device description
OB DELIVERY PACK
Published
2026-09-04
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
MLSLabor and Delivery Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MLSLabor And Delivery KitObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50198956571899PackageGS17In Commercial Distribution
10198956571891PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895657189950198956571899
1019895657189110198956571891

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
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
10198956038127CARDINAL HEALTHSAN22IAMRASAN22IAMRA2026-10-19
10198956180000CARDINAL HEALTHPUV2KPMHBPUV2KPMHB2026-10-19
10198956268111CARDINAL HEALTHSNECGACSGESNECGACSGE2026-10-19
10198956377967CARDINAL HEALTHSBA56MIMCFSBA56MIMCF2026-10-19
10198956384774CARDINAL HEALTHSVA42LVGLCSVA42LVGLC2026-10-19
10198956390799CARDINAL HEALTHSEYCGEPAZBSEYCGEPAZB2026-10-19
10198956400795CARDINAL HEALTHSOP3MKPCVDSOP3MKPCVD2026-10-19
10198956414815CARDINAL HEALTHSMA41PGEPBSMA41PGEPB2026-10-19
10198956441811CARDINAL HEALTHSCV29VPPCUSCV29VPPCU2026-10-19
10198956462328CARDINAL HEALTHSCV13PPBTESCV13PPBTE2026-10-19
10198956464988CARDINAL HEALTHSOP51XRKKPSOP51XRKKP2026-10-19
10198956499270CARDINAL HEALTHPG33BGMKBPG33BGMKB2026-10-19
10198956499980CARDINAL HEALTH33-2528E33-2528E2026-10-19
10198956506732CARDINAL HEALTHSOP41TPDSFSOP41TPDSF2026-10-19
10198956513587CARDINAL HEALTHSAN33CACHNSAN33CACHN2026-10-19
10198956514874CARDINAL HEALTHSOPOCTKSBBSOPOCTKSBB2026-10-19
10198956516922CARDINAL HEALTHPC23TAAMEPC23TAAME2026-10-19
10198956518964CARDINAL HEALTHSAN40CCAEGSAN40CCAEG2026-10-19
10198956519527CARDINAL HEALTH17-7678I17-7678I2026-10-19
10198956519756CARDINAL HEALTHPO33UEVWBPO33UEVWB2026-10-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956589490CARDINAL HEALTHCardinal Health 200, LLCMLS2026-10-19
10198956606937CARDINAL HEALTHCardinal Health 200, LLCMLS2026-10-19
10198956609303CARDINAL HEALTHCardinal Health 200, LLCMLS2026-10-19
10198956606128CARDINAL HEALTHCardinal Health 200, LLCMLS2026-10-15
10198956588721CARDINAL HEALTHCardinal Health 200, LLCMLS2026-10-13
10198956537316CARDINAL HEALTHCardinal Health 200, LLCMLS2026-10-12
10198956569072CARDINAL HEALTHCardinal Health 200, LLCMLS2026-10-12
10198956587229CARDINAL HEALTHCardinal Health 200, LLCMLS2026-10-12
10198956591394CARDINAL HEALTHCardinal Health 200, LLCMLS2026-10-12
10198956594548CARDINAL HEALTHCardinal Health 200, LLCMLS2026-10-12
10198956599154CARDINAL HEALTHCardinal Health 200, LLCMLS2026-10-12
10198956599260CARDINAL HEALTHCardinal Health 200, LLCMLS2026-10-12
10198956601000CARDINAL HEALTHCardinal Health 200, LLCMLS2026-10-12
10198956542129CARDINAL HEALTHCardinal Health 200, LLCMLS2026-10-06
10198956569171CARDINAL HEALTHCardinal Health 200, LLCMLS2026-10-06
10198956559806CARDINAL HEALTHCardinal Health 200, LLCMLS2026-09-30
10198956544703CARDINAL HEALTHCardinal Health 200, LLCMLS2026-09-29
10198956514485CARDINAL HEALTHCardinal Health 200, LLCMLS2026-09-25
10198956575363CARDINAL HEALTHCardinal Health 200, LLCMLS2026-09-25
10198956585546CARDINAL HEALTHCardinal Health 200, LLCMLS2026-09-25
10198956585553CARDINAL HEALTHCardinal Health 200, LLCMLS2026-09-25
10198956543638CARDINAL HEALTHCardinal Health 200, LLCMLS2026-09-22
10198956555372CARDINAL HEALTHCardinal Health 200, LLCMLS2026-09-22
10198956563742CARDINAL HEALTHCardinal Health 200, LLCMLS2026-09-22
10198956579675CARDINAL HEALTHCardinal Health 200, LLCMLS2026-09-22
10198956504158CARDINAL HEALTHCardinal Health 200, LLCMLS2026-09-04
10198956571648CARDINAL HEALTHCardinal Health 200, LLCMLS2026-09-04
10198956572966CARDINAL HEALTHCardinal Health 200, LLCMLS2026-09-04
10198956549685CARDINAL HEALTHCardinal Health 200, LLCMLS2026-08-18
10198956555167CARDINAL HEALTHCardinal Health 200, LLCMLS2026-08-17