FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956494879
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
PL37VDS34
Catalog number
PL37VDS34
Device description
KIT, VAGINAL DELIVERY
Published
2026-06-05
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
MLSLabor and Delivery Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MLSLabor And Delivery KitObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50198956494877PackageGS11In Commercial Distribution
10198956494879PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895649487750198956494877
1019895649487910198956494879

GMDN Terms#

Term, Definition table
TermDefinition
Obstetrical/gynaecological surgical procedure kit, medicatedA collection of various sterile surgical instruments, dressings, pharmaceuticals, and materials intended to be used during obstetrical/gynaecological surgery; it is a general-purpose obstetrical/gynaecological surgical kit, and as such is not dedicated to a specific procedure. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature00

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
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10198956078789CARDINAL HEALTHSBACGTPILESBACGTPILE2026-06-05
10198956231061CARDINAL HEALTHSMA45CSHMCSMA45CSHMC2026-06-05
10198956266063CARDINAL HEALTHSEN32MHRMJSEN32MHRMJ2026-06-05
10198956286665CARDINAL HEALTHPOV2SH01YPOV2SH01Y2026-06-05
10198956305274CARDINAL HEALTHSOP21BPWCBSOP21BPWCB2026-06-05
10198956305861CARDINAL HEALTHSBA30HYCRGSBA30HYCRG2026-06-05
10198956321557CARDINAL HEALTHPVHDMJVCOPVHDMJVCO2026-06-05
10198956330085CARDINAL HEALTHPV13OPEMIPV13OPEMI2026-06-05
10198956332522CARDINAL HEALTHSNE24CRNOOSNE24CRNOO2026-06-05
10198956339231CARDINAL HEALTHSCV22EPSBDSCV22EPSBD2026-06-05
10198956339392CARDINAL HEALTHSBA21BLDCCSBA21BLDCC2026-06-05
10198956344471CARDINAL HEALTHPB4AGYHAFPB4AGYHAF2026-06-05
10198956345928CARDINAL HEALTHSOPOCCAHSCSOPOCCAHSC2026-06-05
10198956349261CARDINAL HEALTHSBA40TRCFESBA40TRCFE2026-06-05
10198956353268CARDINAL HEALTHSCV29SPMMCSCV29SPMMC2026-06-05
10198956354241CARDINAL HEALTHSEN4LHNGRESEN4LHNGRE2026-06-05
10198956359963CARDINAL HEALTHSOP56THIDFSOP56THIDF2026-06-05
10198956364905CARDINAL HEALTHSOP5TKASCFSOP5TKASCF2026-06-05
10198956365902CARDINAL HEALTHSBA22BSSTDSBA22BSSTD2026-06-05
10198956367630CARDINAL HEALTHSOT69CYUSESOT69CYUSE2026-06-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956482128CARDINAL HEALTHCardinal Health 200, LLCMLS2026-06-05
10198956495593CARDINAL HEALTHCardinal Health 200, LLCMLS2026-06-05
10198956499898CARDINAL HEALTHCardinal Health 200, LLCMLS2026-06-05
10198956502215CARDINAL HEALTHCardinal Health 200, LLCMLS2026-06-05
10198956448148CARDINAL HEALTHCardinal Health 200, LLCMLS2026-06-01
10198956481848CARDINAL HEALTHCardinal Health 200, LLCMLS2026-06-01
10198956489400CARDINAL HEALTHCardinal Health 200, LLCMLS2026-06-01
10198956491137CARDINAL HEALTHCardinal Health 200, LLCMLS2026-06-01
10198956492448CARDINAL HEALTHCardinal Health 200, LLCMLS2026-06-01
10193489215052Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLS2023-06-08
10193489215649Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLS2023-06-08
10193489410006Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLS2023-06-08
10193489412673Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLS2023-06-08
10193489414646Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLS2023-06-08
10193489415773Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLS2023-06-08
10193489417289Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLS2023-06-08
10193489418187Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLS2023-06-08
10193489419214Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLS2023-06-08
10193489419290Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLS2023-06-08
10193489419429Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLS2023-06-08
10193489423730Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLS2023-06-08
10193489424089Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLS2023-06-08
10193489426229Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLS2023-06-08
10193489426410Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLS2023-06-08
10193489430202Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLS2023-06-08
10193489443288Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLS2023-06-08
10193489446159Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLS2023-06-08
10193489447286Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLS2023-06-08
10193489454598Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLS2023-06-08
10193489454666Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLS2023-06-08