FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10195594077877
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SNE33CPHRA
Catalog number
SNE33CPHRA
Device description
CERVICAL PACK
Published
2021-06-07
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
OHLPap smear kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OHLPap Smear KitObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50195594077875PackageGS13In Commercial Distribution
10195594077877PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019559407787550195594077875
1019559407787710195594077877

GMDN Terms#

Term, Definition table
TermDefinition
Papanicolaou smear kitA packaged collection of instruments, equipment, and reagents required to obtain a cytology sample from the cervix and perform a Papanicolaou test (PAP). Commonly known as a Pap smear or Pap test the cells are typically smeared onto a microscope slide or mixed in a liquid fixative for microscopic examination. A Pap test is usually done as part of a woman's regular pelvic examination. 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
10885380213281CARDINAL HEALTHCAH4403CAH44032026-05-27
10192253047486Telfa766776672025-09-08
50885380140233CONVERTORS8337N8337N2018-08-20
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
50195594077875CARDINAL HEALTHCardinal Health 200, LLCOHL2021-06-07
10810010890471Aero-MedAERO-MED, LLCOHL2019-01-16
10810010890501Aero-MedAERO-MED, LLCOHL2019-01-16
50810010890479Aero-MedAERO-MED, LLCOHL2019-01-16
50810010890509Aero-MedAERO-MED, LLCOHL2019-01-16
10888439311617CARDINAL HEALTHCardinal Health 200, LLCOHL2019-01-14
50888439311615CARDINAL HEALTHCardinal Health 200, LLCOHL2019-01-14
10887488944845CARDINAL HEALTHCardinal Health 200, LLCOHL2018-04-30
50887488944843CARDINAL HEALTHCardinal Health 200, LLCOHL2018-04-30
10809160158739Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OHL2017-08-11
10809160159125Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OHL2017-08-11
20809160159122Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OHL2017-08-11
00187207000085Andwin ScientificAndwin ScientificOHL2017-08-02
00187207000092Andwin ScientificAndwin ScientificOHL2017-08-02
00187207000108Andwin ScientificAndwin ScientificOHL2017-08-02
00187207000122Andwin ScientificAndwin ScientificOHL2017-08-02
00187207000139Andwin ScientificAndwin ScientificOHL2017-08-02
00187207000146Andwin ScientificAndwin ScientificOHL2017-08-02
00187207000153Andwin ScientificAndwin ScientificOHL2017-08-02
00187207000160Andwin ScientificAndwin ScientificOHL2017-08-02
00187207000177Andwin ScientificAndwin ScientificOHL2017-08-02
00187207000184Andwin ScientificAndwin ScientificOHL2017-08-02
00187207000191Andwin ScientificAndwin ScientificOHL2017-08-02
00187207000207Andwin ScientificAndwin ScientificOHL2017-08-02
00187207000078Andwin ScientificAndwin ScientificOHL2017-08-02
20187207000089Andwin ScientificAndwin ScientificOHL2017-08-02
20187207000096Andwin ScientificAndwin ScientificOHL2017-08-02
20187207000102Andwin ScientificAndwin ScientificOHL2017-08-02
20187207000126Andwin ScientificAndwin ScientificOHL2017-08-02
20187207000133Andwin ScientificAndwin ScientificOHL2017-08-02