FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10888439453256
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SMA31EOCLC
Catalog number
SMA31EOCLC
Device description
EMERGENCY OB KIT
Published
2019-06-04
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
50888439453254PackageGS114In Commercial Distribution
10888439453256PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088843945325450888439453254
1088843945325610888439453256

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 Temperature040 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
20885380173544Curity9022G9022G2019-11-14
20885380173568Curity9024G9024G2019-11-14
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

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
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
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