FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50197106784455
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
29-0083J
Catalog number
29-0083J
Device description
AMNIOCENTESIS TRAY
Published
2024-10-03
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
HIOSampler, amniotic fluid (amniocentesis tray)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HIOSampler, Amniotic Fluid (Amniocentesis Tray)Obstetrics/Gynecology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50197106784455PackageGS115In Commercial Distribution
10197106784457PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710678445550197106784455
1019710678445710197106784457

GMDN Terms#

Term, Definition table
TermDefinition
Amniocentesis kit, medicated, single-useA 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, dressings, and pharmaceuticals. 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.

Sterilization Methods#

Method table
Method

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
10192253047967Kendall92339233-2026-05-26
20192253017615Medi-Trace Cadence22661PC22661PC2021-07-29
20192253019992Kendall33547T33547T--2026-05-26
20885380136617CARDINAL HEALTHN8830N88302019-02-07
20885380136624CARDINAL HEALTHN8831N88312019-02-07
20885380136631CARDINAL HEALTHN8832N88322019-02-07
20885380168069CARDINAL HEALTHC3660PPLC3660PPL2019-04-30
10192253045093KendallMK00175MK001752023-06-15
10192253013016Argyle888875001888887500182022-10-26
10192253013023Argyle888875051388887505132022-10-26
10198956056497CARDINAL HEALTHPN69MSGADPN69MSGAD2026-05-25
10198956057005CARDINAL HEALTHSBACGDPMEDSBACGDPMED2026-05-25
10198956221161CARDINAL HEALTHSOP29PLCCYSOP29PLCCY2026-05-25
10198956253773CARDINAL HEALTHSOP56TKTCCSOP56TKTCC2026-05-25
10198956257610CARDINAL HEALTHSOPOCTKLHKSOPOCTKLHK2026-05-25
10198956258730CARDINAL HEALTHAMN4Q8277CAMN4Q8277C2026-05-25
10198956291812CARDINAL HEALTHSOP4FKPWFBSOP4FKPWFB2026-05-25
10198956300316CARDINAL HEALTH34-2071H34-2071H2026-05-25
10198956321632CARDINAL HEALTHSOPCGKHAUCSOPCGKHAUC2026-05-25
10198956325487CARDINAL HEALTHPO43LEUNCPO43LEUNC2026-05-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
50198956345971CARDINAL HEALTHCardinal Health 200, LLCHIO2026-03-03
50198956309416CARDINAL HEALTHCardinal Health 200, LLCHIO2025-12-26
50198956063646CARDINAL HEALTHCardinal Health 200, LLCHIO2025-07-28
B098R404ROJFB1Aligned Medical SolutionsAligned Medical SolutionsHIO2025-03-17
50197106799572CARDINAL HEALTHCardinal Health 200, LLCHIO2024-10-31
50197106781249CARDINAL HEALTHCardinal Health 200, LLCHIO2024-10-29
50197106704903CARDINAL HEALTHCardinal Health 200, LLCHIO2024-07-09
50197106602421CARDINAL HEALTHCardinal Health 200, LLCHIO2024-04-16
50197106615193CARDINAL HEALTHCardinal Health 200, LLCHIO2024-04-16
00191072215246ACSAMERICAN CONTRACT SYSTEMS, INC.HIO2024-01-12
50197106448692CARDINAL HEALTHCardinal Health 200, LLCHIO2023-12-19
10849233013763Busse Hospital DisposablesROBERT BUSSE & CO., INC.HIO2023-12-12
25060259071304AmnicatorsMEDICAL WIRE & EQUIPMENT CO.(BATH)LIMITEDHIO2023-10-05
05060259071317AmnicatorsMEDICAL WIRE & EQUIPMENT CO.(BATH)LIMITEDHIO2023-10-05
50197106421404CARDINAL HEALTHCardinal Health 200, LLCHIO2023-09-08
50197106234790CARDINAL HEALTHCardinal Health 200, LLCHIO2023-05-23
50197106089000CARDINAL HEALTHCardinal Health 200, LLCHIO2023-02-24
10849233008820Busse Hospital DisposablesROBERT BUSSE & CO., INC.HIO2022-11-14
50195594770226CARDINAL HEALTHCardinal Health 200, LLCHIO2022-10-27
M75257030591Stradis STRADIS MEDICAL, LLCHIO2022-08-09
20886333220797Amniocentesis TrayARGON MEDICAL DEVICES, INC.HIO2022-07-20
20886333220803Amniocentesis TrayARGON MEDICAL DEVICES, INC.HIO2022-07-20
20886333224306Amniocentesis TrayARGON MEDICAL DEVICES, INC.HIO2022-07-20
50195594688415CARDINAL HEALTHCardinal Health 200, LLCHIO2022-07-07
50195594673848CARDINAL HEALTHCardinal Health 200, LLCHIO2022-05-13
H65857030591Henry ScheinHENRY SCHEIN, INC.HIO2022-04-26
M75257026860STRADIS HEALTHCARESTRADIS MEDICAL, LLCHIO2022-03-10
M75257014560STRADIS HEALTHCARESTRADIS MEDICAL, LLCHIO2022-03-07
50888439858370CARDINAL HEALTHCardinal Health 200, LLCHIO2022-01-07
50195594409034CARDINAL HEALTHCardinal Health 200, LLCHIO2021-11-30