FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956572041
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SMA13CKTMD
Catalog number
SMA13CKTMD
Device description
C SECTION PACK
Published
2026-09-25
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
OHMCesarean section tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OHMCesarean Section TrayObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50198956572049PackageGS12In Commercial Distribution
10198956572041PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895657204950198956572049
1019895657204110198956572041

GMDN Terms#

Term, Definition table
TermDefinition
Birthing/delivery kitA collection of sterile devices designed for the procedures associated with the birthing and delivery of a newborn. It contains the necessary instruments, dressings, and pharmaceuticals necessary for this procedure. 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
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
10198956588738CARDINAL HEALTHCardinal Health 200, LLCOHM2026-10-19
10198956592407CARDINAL HEALTHCardinal Health 200, LLCOHM2026-10-19
10198956602380CARDINAL HEALTHCardinal Health 200, LLCOHM2026-10-19
10198956605534CARDINAL HEALTHCardinal Health 200, LLCOHM2026-10-19
10198956606654CARDINAL HEALTHCardinal Health 200, LLCOHM2026-10-19
10198956612099CARDINAL HEALTHCardinal Health 200, LLCOHM2026-10-19
10198956598478CARDINAL HEALTHCardinal Health 200, LLCOHM2026-10-15
10198956601345CARDINAL HEALTHCardinal Health 200, LLCOHM2026-10-15
10198956604285CARDINAL HEALTHCardinal Health 200, LLCOHM2026-10-15
10198956608726CARDINAL HEALTHCardinal Health 200, LLCOHM2026-10-15
10198956545267CARDINAL HEALTHCardinal Health 200, LLCOHM2026-10-12
10198956569003CARDINAL HEALTHCardinal Health 200, LLCOHM2026-10-12
10198956598751CARDINAL HEALTHCardinal Health 200, LLCOHM2026-10-12
10198956599130CARDINAL HEALTHCardinal Health 200, LLCOHM2026-10-12
10198956348776CARDINAL HEALTHCardinal Health 200, LLCOHM2026-10-06
10198956573291CARDINAL HEALTHCardinal Health 200, LLCOHM2026-10-06
10198956580121CARDINAL HEALTHCardinal Health 200, LLCOHM2026-10-06
10198956596771CARDINAL HEALTHCardinal Health 200, LLCOHM2026-10-06
10198956558328CARDINAL HEALTHCardinal Health 200, LLCOHM2026-09-30
10198956591769CARDINAL HEALTHCardinal Health 200, LLCOHM2026-09-30
10198956596368CARDINAL HEALTHCardinal Health 200, LLCOHM2026-09-30
10198956598423CARDINAL HEALTHCardinal Health 200, LLCOHM2026-09-30
10198956450684CARDINAL HEALTHCardinal Health 200, LLCOHM2026-09-25
10198956519022CARDINAL HEALTHCardinal Health 200, LLCOHM2026-09-25
10198956557574CARDINAL HEALTHCardinal Health 200, LLCOHM2026-09-25
10198956568136CARDINAL HEALTHCardinal Health 200, LLCOHM2026-09-25
10198956580848CARDINAL HEALTHCardinal Health 200, LLCOHM2026-09-25
10198956586000CARDINAL HEALTHCardinal Health 200, LLCOHM2026-09-25
10198956589186CARDINAL HEALTHCardinal Health 200, LLCOHM2026-09-25
10198956271418CARDINAL HEALTHCardinal Health 200, LLCOHM2026-09-22