FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10887488684895
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SMA31EOCLB
Catalog number
SMA31EOCLB
Device description
STERILE EMERGENCY OB KIT
Published
2017-03-22
Public version status
Update
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
50887488684893PackageGS114In Commercial Distribution
10887488684895PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088748868489350887488684893
1088748868489510887488684895

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
10885380152412CARDINAL HEALTHCAX2304BACAX2304BA2017-10-12
10885380152429CARDINAL HEALTHCAX2304BDCAX2304BD2017-10-12
10885380152559CARDINAL HEALTHCAX2330LACAX2330LA2021-10-27
10885380152566CARDINAL HEALTHCAX2330LDCAX2330LD2021-10-27
10885380171109CARDINAL HEALTHCAX1230LACAX1230LA2020-06-21
10885380171116CARDINAL HEALTHCAX1230LDCAX1230LD2020-06-21
10885380171147CARDINAL HEALTHCAX3030LACAX3030LA2020-06-21
10885380171154CARDINAL HEALTHCAX3030LDCAX3030LD2020-06-21
10885380164545CARDINAL HEALTHCAX5030LACAX5030LA2020-03-18
10885380164552CARDINAL HEALTHCAX5030LDCAX5030LD2020-03-18
10198956286306CARDINAL HEALTHSOPOCLRWSHSOPOCLRWSH2026-08-26
10198956330221CARDINAL HEALTHSBA5FLCABBSBA5FLCABB2026-08-26
10198956346246CARDINAL HEALTHSCVHDVPAGCSCVHDVPAGC2026-08-26
10198956373105CARDINAL HEALTHSNE43LMSUBSNE43LMSUB2026-08-26
10198956384330CARDINAL HEALTHSMA45DCWPBSMA45DCWPB2026-08-26
10198956409767CARDINAL HEALTHSEN18EAVBOSEN18EAVBO2026-08-26
10198956417533CARDINAL HEALTHSEY13EPLHMSEY13EPLHM2026-08-26
10198956423633CARDINAL HEALTHPOCGEXBLJPOCGEXBLJ2026-08-26
10198956437746CARDINAL HEALTH38-8433D38-8433D2026-08-26
10198956461048CARDINAL HEALTHSOP18FTSTMSOP18FTSTM2026-08-26

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