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
10192253072037CARDINAL HEALTHALMASK5ALMASK52026-07-29
10192253072044CARDINAL HEALTHAMMASK4AMMASK42026-07-29
10192253072051CARDINAL HEALTHAXLMASK6AXLMASK62026-07-29
10192253072068CARDINAL HEALTHCHIMASK3CHIMASK32026-07-29
10192253072075CARDINAL HEALTHINFMASK1INFMASK12026-07-29
10192253072082CARDINAL HEALTHNEOMASK0NEOMASK02026-07-29
10192253072105CARDINAL HEALTHTODMASK2TODMASK22026-07-29
10192253025699Dover888876051688887605162023-11-21
10192253025705Dover888876051888887605182023-11-21
10192253025712Dover888876052088887605202023-11-21
10192253025750Dover888876301888887630182023-11-21
10192253025774Dover888876302288887630222023-11-21
10192253026344Dover35603560-2022-04-12
10192253028201Dover62086208-2024-10-14
10192253030365Dover888849206688884920662025-04-07
10192253031836DoverP4P16ULDP4P16ULD-2024-08-22
10192253068573Dover33053305-2026-01-16
10192253068634Dover61556155-2026-01-16
10197106541029CARDINAL HEALTH01A1360C01A1360C2024-03-06
10197106741030CARDINAL HEALTH03-2242D03-2242D2024-09-27

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