FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10888439835250
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SMARPOEHFA
Catalog number
SMARPOEHFA
Device description
OB EMERGENCY PACK
Published
2020-07-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
OKUEmergency obstetrical kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OKUEmergency Obstetrical KitObstetrics/Gynecology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50888439835258PackageGS14In Commercial Distribution
10888439835250PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088843983525850888439835258
1088843983525010888439835250

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 Temperature15 Degrees Celsius30 Degrees Celsius

Regulatory Flags#

DUNS number
961027315
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10192253047967Kendall92339233-2026-05-26
20192253019992Kendall33547T33547T--2026-05-26
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
10198956328457CARDINAL HEALTHPG4ETRHTCPG4ETRHTC2026-05-25
10198956340435CARDINAL HEALTH08-4609B08-4609B2026-05-25
10198956345645CARDINAL HEALTHSEYCGVPCPHSEYCGVPCPH2026-05-25
10198956348189CARDINAL HEALTHSBA48PPNSESBA48PPNSE2026-05-25
10198956350205CARDINAL HEALTHORC431774CORC431774C2026-05-25
10198956354517CARDINAL HEALTHSOP44TSTODSOP44TSTOD2026-05-25
10198956358003CARDINAL HEALTHSOT53CYPZDSOT53CYPZD2026-05-25
10198956358904CARDINAL HEALTHSOP53ACVLFSOP53ACVLF2026-05-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810094579258Curaplex®BOUND TREE MEDICAL, LLCOKU2025-07-09
00810094579265Curaplex®BOUND TREE MEDICAL, LLCOKU2025-07-09
00810094577223CuraplexBOUND TREE MEDICAL, LLCOKU2024-09-30
00810094577131CuraplexBOUND TREE MEDICAL, LLCOKU2024-07-30
00810094577148CuraplexBOUND TREE MEDICAL, LLCOKU2024-07-30
00810094576325CuraplexBOUND TREE MEDICAL, LLCOKU2023-11-10
10195594387662CARDINAL HEALTHCardinal Health 200, LLCOKU2022-05-09
50195594387660CARDINAL HEALTHCardinal Health 200, LLCOKU2022-05-09
10195594515980CARDINAL HEALTHCardinal Health 200, LLCOKU2022-01-23
50195594515988CARDINAL HEALTHCardinal Health 200, LLCOKU2022-01-23
00810071631474CuraplexBOUND TREE MEDICAL, LLCOKU2021-04-01
00810071631535CURAPLEXBOUND TREE MEDICAL, LLCOKU2021-04-01
00812277036596CuraplexBOUND TREE MEDICAL, LLCOKU2020-11-30
50888439835258CARDINAL HEALTHCardinal Health 200, LLCOKU2020-07-21
00812277035940CuraplexBOUND TREE MEDICAL, LLCOKU2019-12-30
00812277035889CuraplexBOUND TREE MEDICAL, LLCOKU2019-12-30
00812277035919CuraplexBOUND TREE MEDICAL, LLCOKU2019-12-30
00812277035988CuraplexBOUND TREE MEDICAL, LLCOKU2019-12-30
00812277036060CuraplexBOUND TREE MEDICAL, LLCOKU2019-12-30
00647921098107MORRISON MEDICALMORRISON MEDICAL, LTDOKU2019-11-07
00647921098206MORRISON MEDICALMORRISON MEDICAL, LTDOKU2019-11-07
00647921096004MORRISON MEDICALMORRISON MEDICAL, LTDOKU2019-10-01
00647921096202MORRISON MEDICALMORRISON MEDICAL, LTDOKU2019-10-01
00647921096301MORRISON MEDICALMORRISON MEDICAL, LTDOKU2019-10-01
00647921096400MORRISON MEDICALMORRISON MEDICAL, LTDOKU2019-10-01
00647921096509MORRISON MEDICALMORRISON MEDICAL, LTDOKU2019-10-01
00647921096516MORRISON MEDICALMORRISON MEDICAL, LTDOKU2019-10-01
00647921096523MORRISON MEDICALMORRISON MEDICAL, LTDOKU2019-10-01
00647921096530MORRISON MEDICALMORRISON MEDICAL, LTDOKU2019-10-01
00647921096608MORRISON MEDICALMORRISON MEDICAL, LTDOKU2019-10-01