FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956569003
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SMA21SBPMB
Catalog number
SMA21SBPMB
Device description
C SECTION PACK B
Published
2026-10-12
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
OHMCesarean section tray

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50198956569001PackageGS12In Commercial Distribution
10198956569003PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895656900150198956569001
1019895656900310198956569003

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.

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
10198956537798CARDINAL HEALTHSOP53TOWRGSOP53TOWRG2026-10-13
10198956539914CARDINAL HEALTHSOP48EX85ASOP48EX85A2026-10-13
10198956541658CARDINAL HEALTHSAN1DRPUNCSAN1DRPUNC2026-10-13
10198956545182CARDINAL HEALTHSOP53SLVLLSOP53SLVLL2026-10-13
10198956549050CARDINAL HEALTHSOP45THBMJSOP45THBMJ2026-10-13
10198956559516CARDINAL HEALTH08-0857C08-0857C2026-10-13
10198956562950CARDINAL HEALTHSBA43MPMADSBA43MPMAD2026-10-13
10198956563223CARDINAL HEALTHSOP42ARBTHSOP42ARBTH2026-10-13
10198956564237CARDINAL HEALTHSEY45BPPAESEY45BPPAE2026-10-13
10198956570740CARDINAL HEALTHSEN48ESSNASEN48ESSNA2026-10-13
10198956570993CARDINAL HEALTH34-2403F34-2403F2026-10-13
10198956573024CARDINAL HEALTHSMA54MGFMPSMA54MGFMP2026-10-13
10198956577084CARDINAL HEALTH08-0857D08-0857D2026-10-13
10198956578753CARDINAL HEALTH34-7753A34-7753A2026-10-13
10198956588721CARDINAL HEALTHSMA40DERWDSMA40DERWD2026-10-13
10198956589810CARDINAL HEALTHSBAOCRPS30SBAOCRPS302026-10-13
10198956592698CARDINAL HEALTHSAN53ANOV6SAN53ANOV62026-10-13
10198956593770CARDINAL HEALTHSOTOCURGR3SOTOCURGR32026-10-13
10198956595071CARDINAL HEALTH31-826AW31-826AW2026-10-13
10198956597891CARDINAL HEALTHSBA43RPUSESBA43RPUSE2026-10-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956545267CARDINAL 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
10198956572041CARDINAL 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
10198956576902CARDINAL HEALTHCardinal Health 200, LLCOHM2026-09-22
10198956580596CARDINAL HEALTHCardinal Health 200, LLCOHM2026-09-22
10198956584587CARDINAL HEALTHCardinal Health 200, LLCOHM2026-09-22
10198956584600CARDINAL HEALTHCardinal Health 200, LLCOHM2026-09-22
10198956587090CARDINAL HEALTHCardinal Health 200, LLCOHM2026-09-22
10198956450417CARDINAL HEALTHCardinal Health 200, LLCOHM2026-09-21
10809160538364HalyardMEDICAL ACTION INDUSTRIES INC.OHM2026-09-21
10198956514461CARDINAL HEALTHCardinal Health 200, LLCOHM2026-09-04
10198956556676CARDINAL HEALTHCardinal Health 200, LLCOHM2026-09-04
10198956562288CARDINAL HEALTHCardinal Health 200, LLCOHM2026-09-04