FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956572966
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
PLVNVDC14
Catalog number
PLVNVDC14
Device description
KIT, VAGINAL DELIVERY, CHS
Published
2026-09-04
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
50198956572964PackageGS14In Commercial Distribution
10198956572966PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895657296450198956572964
1019895657296610198956572966

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.

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
10198956037908CARDINAL HEALTH08-3641G08-3641G2026-09-04
10198956210240CARDINAL HEALTHAMN213116EAMN213116E2026-09-04
10198956310933CARDINAL HEALTHANE439532GANE439532G2026-09-04
10198956331891CARDINAL HEALTHSAN13ARBIFSAN13ARBIF2026-09-04
10198956333420CARDINAL HEALTHSANX4IPSSCSANX4IPSSC2026-09-04
10198956359291CARDINAL HEALTHSMA54BGEVCSMA54BGEVC2026-09-04
10198956379084CARDINAL HEALTHSOP33EXMSGSOP33EXMSG2026-09-04
10198956395947CARDINAL HEALTHSOPMIMPMSBSOPMIMPMSB2026-09-04
10198956398467CARDINAL HEALTHSBA44LPCEASBA44LPCEA2026-09-04
10198956415195CARDINAL HEALTHSCVCGOHILHSCVCGOHILH2026-09-04
10198956421462CARDINAL HEALTHSOPMVSAUCJSOPMVSAUCJ2026-09-04
10198956426061CARDINAL HEALTHSCVDKMVOGDSCVDKMVOGD2026-09-04
10198956428102CARDINAL HEALTHSAN13RDEMSSAN13RDEMS2026-09-04
10198956454989CARDINAL HEALTHSOP23KPNLCSOP23KPNLC2026-09-04
10198956462977CARDINAL HEALTHSBA48LCRHCSBA48LCRHC2026-09-04
10198956463394CARDINAL HEALTHSEN23TAPCLSEN23TAPCL2026-09-04
10198956464520CARDINAL HEALTHSMA23GPNVBSMA23GPNVB2026-09-04
10198956465510CARDINAL HEALTH34-3217C34-3217C2026-09-04
10198956468399CARDINAL HEALTHPO1DTHAMQPO1DTHAMQ2026-09-04
10198956468481CARDINAL HEALTHSMAOCGLSTGSMAOCGLSTG2026-09-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956504158CARDINAL HEALTHCardinal Health 200, LLCMLS2026-09-04
10198956571648CARDINAL HEALTHCardinal Health 200, LLCMLS2026-09-04
10198956571891CARDINAL HEALTHCardinal Health 200, LLCMLS2026-09-04
10198956549685CARDINAL HEALTHCardinal Health 200, LLCMLS2026-08-18
10198956555167CARDINAL HEALTHCardinal Health 200, LLCMLS2026-08-17
10198956541337CARDINAL HEALTHCardinal Health 200, LLCMLS2026-07-31
10809160527894HalyardAVID MEDICAL, INC.MLS2026-07-28
10809160527900HalyardAVID MEDICAL, INC.MLS2026-07-28
10198956412262CARDINAL HEALTHCardinal Health 200, LLCMLS2026-07-27
10198956467903CARDINAL HEALTHCardinal Health 200, LLCMLS2026-07-27
10198956483996CARDINAL HEALTHCardinal Health 200, LLCMLS2026-07-27
10198956495883CARDINAL HEALTHCardinal Health 200, LLCMLS2026-07-27
10198956511453CARDINAL HEALTHCardinal Health 200, LLCMLS2026-07-27
10198956514065CARDINAL HEALTHCardinal Health 200, LLCMLS2026-07-27
10198956527935CARDINAL HEALTHCardinal Health 200, LLCMLS2026-07-27
10198956534766CARDINAL HEALTHCardinal Health 200, LLCMLS2026-07-27
10198956535312CARDINAL HEALTHCardinal Health 200, LLCMLS2026-07-27
10198956536289CARDINAL HEALTHCardinal Health 200, LLCMLS2026-07-27
10198956537026CARDINAL HEALTHCardinal Health 200, LLCMLS2026-07-27
10198956461154CARDINAL HEALTHCardinal Health 200, LLCMLS2026-07-20
10198956463721CARDINAL HEALTHCardinal Health 200, LLCMLS2026-07-20
10198956514768CARDINAL HEALTHCardinal Health 200, LLCMLS2026-07-20
10198956531376CARDINAL HEALTHCardinal Health 200, LLCMLS2026-07-20
10198956532861CARDINAL HEALTHCardinal Health 200, LLCMLS2026-07-20
10198956501935CARDINAL HEALTHCardinal Health 200, LLCMLS2026-07-16
10198956520073CARDINAL HEALTHCardinal Health 200, LLCMLS2026-07-16
10198956505414CARDINAL HEALTHCardinal Health 200, LLCMLS2026-07-09
10198956527492CARDINAL HEALTHCardinal Health 200, LLCMLS2026-07-09
10198956491045CARDINAL HEALTHCardinal Health 200, LLCMLS2026-07-06
10198956492134CARDINAL HEALTHCardinal Health 200, LLCMLS2026-07-06