FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956579675
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
PL21VDC18
Catalog number
PL21VDC18
Device description
KIT, CANDLER VAGINAL DELIVERY
Published
2026-09-22
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
50198956579673PackageGS12In Commercial Distribution
10198956579675PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895657967350198956579673
1019895657967510198956579675

GMDN Terms#

Term, Definition table
TermDefinition
Birthing/delivery kitA collection of sterile devices designed for the procedures associated with the birthing and delivery of a newborn. It contains the necessary instruments, dressings, and pharmaceuticals necessary for this 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
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10198956448025CARDINAL HEALTH11-9002NSC11-9002NSC2026-10-15
10198956531666CARDINAL HEALTH03L2276A03L2276A2026-10-15
10198956538030CARDINAL HEALTHSOP48KASUFSOP48KASUF2026-10-15
10198956542075CARDINAL HEALTH34-8052I34-8052I2026-10-15
10198956543577CARDINAL HEALTHSNE21CRCAHSNE21CRCAH2026-10-15
10198956544017CARDINAL HEALTHSMA54RPUPFSMA54RPUPF2026-10-15
10198956546424CARDINAL HEALTHSOP53SAFOHSOP53SAFOH2026-10-15
10198956549760CARDINAL HEALTHSUT11BAMMCSUT11BAMMC2026-10-15
10198956555211CARDINAL HEALTHSOP43KAIBDSOP43KAIBD2026-10-15
10198956560765CARDINAL HEALTHSAN54SMPTDSAN54SMPTD2026-10-15
10198956561311CARDINAL HEALTHPO54PSJHCPO54PSJHC2026-10-15
10198956562523CARDINAL HEALTH34-9491A34-9491A2026-10-15
10198956563056CARDINAL HEALTH34B0820I34B0820I2026-10-15
10198956565388CARDINAL HEALTHPUMHPY12APUMHPY12A2026-10-15
10198956565470CARDINAL HEALTH03-2757O03-2757O2026-10-15
10198956565883CARDINAL HEALTH34-2121F34-2121F2026-10-15
10198956566613CARDINAL HEALTHSBA53BPPNDSBA53BPPND2026-10-15
10198956568969CARDINAL HEALTH34-9232B34-9232B2026-10-15
10198956569416CARDINAL HEALTHSOT48VYIWBSOT48VYIWB2026-10-15
10198956569966CARDINAL HEALTH07-8497A07-8497A2026-10-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956606128CARDINAL HEALTHCardinal Health 200, LLCMLS2026-10-15
10198956588721CARDINAL HEALTHCardinal Health 200, LLCMLS2026-10-13
10198956537316CARDINAL HEALTHCardinal Health 200, LLCMLS2026-10-12
10198956569072CARDINAL HEALTHCardinal Health 200, LLCMLS2026-10-12
10198956587229CARDINAL HEALTHCardinal Health 200, LLCMLS2026-10-12
10198956591394CARDINAL HEALTHCardinal Health 200, LLCMLS2026-10-12
10198956594548CARDINAL HEALTHCardinal Health 200, LLCMLS2026-10-12
10198956599154CARDINAL HEALTHCardinal Health 200, LLCMLS2026-10-12
10198956599260CARDINAL HEALTHCardinal Health 200, LLCMLS2026-10-12
10198956601000CARDINAL HEALTHCardinal Health 200, LLCMLS2026-10-12
10198956542129CARDINAL HEALTHCardinal Health 200, LLCMLS2026-10-06
10198956569171CARDINAL HEALTHCardinal Health 200, LLCMLS2026-10-06
10198956559806CARDINAL HEALTHCardinal Health 200, LLCMLS2026-09-30
10198956544703CARDINAL HEALTHCardinal Health 200, LLCMLS2026-09-29
10198956514485CARDINAL HEALTHCardinal Health 200, LLCMLS2026-09-25
10198956575363CARDINAL HEALTHCardinal Health 200, LLCMLS2026-09-25
10198956585546CARDINAL HEALTHCardinal Health 200, LLCMLS2026-09-25
10198956585553CARDINAL HEALTHCardinal Health 200, LLCMLS2026-09-25
10198956543638CARDINAL HEALTHCardinal Health 200, LLCMLS2026-09-22
10198956555372CARDINAL HEALTHCardinal Health 200, LLCMLS2026-09-22
10198956563742CARDINAL HEALTHCardinal Health 200, LLCMLS2026-09-22
10198956504158CARDINAL HEALTHCardinal Health 200, LLCMLS2026-09-04
10198956571648CARDINAL HEALTHCardinal Health 200, LLCMLS2026-09-04
10198956571891CARDINAL HEALTHCardinal Health 200, LLCMLS2026-09-04
10198956572966CARDINAL 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