FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10195594387662
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SMARPOEHFB
Catalog number
SMARPOEHFB
Device description
OB EMERGENCY PACK
Published
2022-05-09
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
50195594387660PackageGS14In Commercial Distribution
10195594387662PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019559438766050195594387660
1019559438766210195594387662

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
10197106992753CARDINAL HEALTHSCV40VP52CSCV40VP52C2026-09-25
10198956169357CARDINAL HEALTHSCV69EVWKASCV69EVWKA2026-09-25
10198956172715CARDINAL HEALTHSBA21PPSCCSBA21PPSCC2026-09-25
10198956321335CARDINAL HEALTHPEHDTRVCKPEHDTRVCK2026-09-25
10198956339729CARDINAL HEALTHSBA22ATMRASBA22ATMRA2026-09-25
10198956374232CARDINAL HEALTHSOP41KASRBSOP41KASRB2026-09-25
10198956383043CARDINAL HEALTHORC3R7765BORC3R7765B2026-09-25
10198956388239CARDINAL HEALTHSOT53CYPOFSOT53CYPOF2026-09-25
10198956393288CARDINAL HEALTHSBA73GPMVBSBA73GPMVB2026-09-25
10198956400801CARDINAL HEALTHSOP3MHPCVCSOP3MHPCVC2026-09-25
10198956402522CARDINAL HEALTHSMA13GLEXDSMA13GLEXD2026-09-25
10198956424654CARDINAL HEALTHPO54TKCMDPO54TKCMD2026-09-25
10198956439849CARDINAL HEALTHSAN69PCKOGSAN69PCKOG2026-09-25
10198956444263CARDINAL HEALTHPV36HPCHEPV36HPCHE2026-09-25
10198956450684CARDINAL HEALTHSMA58CSLOPSMA58CSLOP2026-09-25
10198956461086CARDINAL HEALTHSBACGBPGSHSBACGBPGSH2026-09-25
10198956462205CARDINAL HEALTHPV08TCGHHPV08TCGHH2026-09-25
10198956466159CARDINAL HEALTH03-2656S03-2656S2026-09-25
10198956466838CARDINAL HEALTHSNE35LSFSGSNE35LSFSG2026-09-25
10198956484382CARDINAL HEALTHANE306276AANE306276A2026-09-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956512832CARDINAL HEALTHCardinal Health 200, LLCOKU2026-07-27
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
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
10888439835250CARDINAL HEALTHCardinal Health 200, LLCOKU2020-07-21
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