FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10197106191798
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SMA11CSJHQ
Catalog number
SMA11CSJHQ
Device description
C BIRTH PK
Published
2023-06-12
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
OHFCuldocentesis kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OHFCuldocentesis KitObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50197106191796PackageGS13In Commercial Distribution
10197106191798PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710619179650197106191796
1019710619179810197106191798

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
50197106191796CARDINAL HEALTHCardinal Health 200, LLCOHF2023-06-12
10197106096727CARDINAL HEALTHCardinal Health 200, LLCOHF2023-01-26
10195594673857CARDINAL HEALTHCardinal Health 200, LLCOHF2022-05-13
50195594673855CARDINAL HEALTHCardinal Health 200, LLCOHF2022-05-13
10195594464233CARDINAL HEALTHCardinal Health 200, LLCOHF2021-11-23
50195594464231CARDINAL HEALTHCardinal Health 200, LLCOHF2021-11-23
10887488897677CARDINAL HEALTHCardinal Health 200, LLCOHF2018-02-09
10887488851730CARDINAL HEALTHCardinal Health 200, LLCOHF2017-11-07
10887488613734CARDINAL HEALTHCardinal Health 200, LLCOHF2016-11-01
10887488380247CARDINAL HEALTHCardinal Health 200, LLCOHF2016-07-14
10887488344928CARDINAL HEALTHCardinal Health 200, LLCOHF2016-07-11