FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50197106952083
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SMA33PLAH3
Catalog number
SMA33PLAH3
Device description
PELVIC LOWER PACK AHN
Published
2025-02-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
MLTPelvic exam kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MLTPelvic Exam KitObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50197106952083PackageGS11In Commercial Distribution
10197106952085PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710695208350197106952083
1019710695208510197106952085

GMDN Terms#

Term, Definition table
TermDefinition
Pelvic examination kitA collection of sterile devices designed to perform a pelvic examination. It contains all of the various instruments, specimen collection materials, and pharmaceuticals necessary for this procedure. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
961027315
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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
10198956327320CARDINAL HEALTHCardinal Health 200, LLCMLT2026-03-09
10198956270275CARDINAL HEALTHCardinal Health 200, LLCMLT2025-12-11
10198956273535CARDINAL HEALTHCardinal Health 200, LLCMLT2025-12-11
10198956210851CARDINAL HEALTHCardinal Health 200, LLCMLT2025-11-21
10198459445217MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.MLT2025-07-28
10198459383748MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.MLT2025-07-02
10198459389207MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.MLT2025-07-02
10198459363726MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.MLT2025-06-09
10198459351747MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.MLT2025-06-02
10198956037649CARDINAL HEALTHCardinal Health 200, LLCMLT2025-05-21
10198459323713Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLT2025-04-18
10198459325137Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLT2025-04-18
10198459326226Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLT2025-04-18
10198459315817Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLT2025-04-07
10198956019089CARDINAL HEALTHCardinal Health 200, LLCMLT2025-04-03
10197106946367CARDINAL HEALTHCardinal Health 200, LLCMLT2025-03-17
10198459273551Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLT2025-03-02
10198459268724Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLT2025-02-23
10197106952085CARDINAL HEALTHCardinal Health 200, LLCMLT2025-02-17
10198459257025Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLT2025-02-09
10197106921029CARDINAL HEALTHCardinal Health 200, LLCMLT2025-01-28
10197106641224CARDINAL HEALTHCardinal Health 200, LLCMLT2025-01-09
10197106899830CARDINAL HEALTHCardinal Health 200, LLCMLT2025-01-09
10198459222047Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLT2024-12-29
10198459225567Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLT2024-12-29
10198459218002Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLT2024-12-22
10198459219467Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLT2024-12-22
10198459200762Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLT2024-12-01
10198459192463Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLT2024-11-24
10198459173226Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLT2024-11-17