FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956535381
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
PL45CPVH4
Catalog number
PL45CPVH4
Device description
KIT, C SECTION
Published
2026-07-27
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
OHMCesarean section tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OHMCesarean Section TrayObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50198956535389PackageGS12In Commercial Distribution
10198956535381PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895653538950198956535389
1019895653538110198956535381

GMDN Terms#

Term, Definition table
TermDefinition
Amniocentesis kit, non-medicatedA collection of sterile devices designed to aspirate and contain a sample of amniotic fluid from the amniotic sac, via a transabdominal approach, for analysis. Components typically include a needle with stylet and syringe, specimen containers/medium, drapes, and dressings. The device is typically used at 16-18 weeks gestation for antepartum diagnosis of certain congenital abnormalities (e.g., Down syndrome, spina bifida), or anytime after 24-weeks gestation to assess foetal maturity. 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
10192253072037CARDINAL HEALTHALMASK5ALMASK52026-07-29
10192253072044CARDINAL HEALTHAMMASK4AMMASK42026-07-29
10192253072051CARDINAL HEALTHAXLMASK6AXLMASK62026-07-29
10192253072068CARDINAL HEALTHCHIMASK3CHIMASK32026-07-29
10192253072075CARDINAL HEALTHINFMASK1INFMASK12026-07-29
10192253072082CARDINAL HEALTHNEOMASK0NEOMASK02026-07-29
10192253072105CARDINAL HEALTHTODMASK2TODMASK22026-07-29
10192253025699Dover888876051688887605162023-11-21
10192253025705Dover888876051888887605182023-11-21
10192253025712Dover888876052088887605202023-11-21
10192253025750Dover888876301888887630182023-11-21
10192253025774Dover888876302288887630222023-11-21
10192253026344Dover35603560-2022-04-12
10192253028201Dover62086208-2024-10-14
10192253030365Dover888849206688884920662025-04-07
10192253031836DoverP4P16ULDP4P16ULD-2024-08-22
10192253068573Dover33053305-2026-01-16
10192253068634Dover61556155-2026-01-16
10197106541029CARDINAL HEALTH01A1360C01A1360C2024-03-06
10197106741030CARDINAL HEALTH03-2242D03-2242D2024-09-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956360150CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-27
10198956467965CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-27
10198956481602CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-27
10198956490017CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-27
10198956508750CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-27
10198956510067CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-27
10198956519916CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-27
10198956529274CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-27
10198956531543CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-27
10198956531918CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-27
10198956533936CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-27
10198956534179CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-27
10198956534957CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-27
10198956536005CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-27
10198956536982CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-27
10198956406162CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-20
10198956454446CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-20
10198956490994CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-20
10198956491694CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-20
10198956502086CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-20
10198956505216CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-20
10198956506510CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-20
10198956512245CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-20
10198956512986CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-20
10198956532212CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-20
10198956532540CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-20
10198956445048CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-16
10198956496422CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-16
10198956506442CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-16
10198956529038CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-16