FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10197106517369
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
PLCGVDBM1
Catalog number
PLCGVDBM1
Device description
KIT, BAL VAGINAL DELIVERY
Published
2023-12-22
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
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
50197106517367PackageGS12In Commercial Distribution
10197106517369PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710651736750197106517367
1019710651736910197106517369

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 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
10198956428201CARDINAL HEALTH26-2755C26-2755C2026-10-01
10198956512474CARDINAL HEALTH28A5420I28A5420I2026-10-01
10198956524316CARDINAL HEALTH34A5387R34A5387R2026-10-01
10198956537385CARDINAL HEALTH28-6325B28-6325B2026-10-01
10198956563087CARDINAL HEALTH34-2454E34-2454E2026-10-01
10198956587298CARDINAL HEALTH40-6487C40-6487C2026-10-01
10885380214714Curity8441368441362026-09-30
10885380214738Curity8441568441562026-09-30
10885380214707Curity8441268441262026-09-28
10885380214721Curity8441468441462026-09-28
10885380214745Curity8441668441662026-09-28
10885380214752Curity8441768441762026-09-28
10885380214769Curity8442168442162026-09-28
10885380214776Curity8442268442262026-09-28
10885380214783Curity8442368442362026-09-28
10885380214790Curity8442468442462026-09-28
10885380214806Curity8442568442562026-09-28
20192253017561Medi-Trace Cadence22660P22660P2024-02-28
20192253017608Medi-Trace Cadence22660R22660R-2024-02-28
50885380050365CARDINAL HEALTHCA901CHCA901CH2021-06-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
10198956579675CARDINAL 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
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