FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10197106799574
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
29-0083K
Catalog number
29-0083K
Device description
AMNIOCENTESIS TRAY
Published
2024-10-31
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
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
50197106799572PackageGS115In Commercial Distribution
10197106799574PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710679957250197106799572
1019710679957410197106799574

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature040 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
10885380152412CARDINAL HEALTHCAX2304BACAX2304BA2017-10-12
10885380152429CARDINAL HEALTHCAX2304BDCAX2304BD2017-10-12
10885380152559CARDINAL HEALTHCAX2330LACAX2330LA2021-10-27
10885380152566CARDINAL HEALTHCAX2330LDCAX2330LD2021-10-27
10885380171109CARDINAL HEALTHCAX1230LACAX1230LA2020-06-21
10885380171116CARDINAL HEALTHCAX1230LDCAX1230LD2020-06-21
10885380171147CARDINAL HEALTHCAX3030LACAX3030LA2020-06-21
10885380171154CARDINAL HEALTHCAX3030LDCAX3030LD2020-06-21
10885380164545CARDINAL HEALTHCAX5030LACAX5030LA2020-03-18
10885380164552CARDINAL HEALTHCAX5030LDCAX5030LD2020-03-18
10198956286306CARDINAL HEALTHSOPOCLRWSHSOPOCLRWSH2026-08-26
10198956330221CARDINAL HEALTHSBA5FLCABBSBA5FLCABB2026-08-26
10198956346246CARDINAL HEALTHSCVHDVPAGCSCVHDVPAGC2026-08-26
10198956373105CARDINAL HEALTHSNE43LMSUBSNE43LMSUB2026-08-26
10198956384330CARDINAL HEALTHSMA45DCWPBSMA45DCWPB2026-08-26
10198956409767CARDINAL HEALTHSEN18EAVBOSEN18EAVBO2026-08-26
10198956417533CARDINAL HEALTHSEY13EPLHMSEY13EPLHM2026-08-26
10198956423633CARDINAL HEALTHPOCGEXBLJPOCGEXBLJ2026-08-26
10198956437746CARDINAL HEALTH38-8433D38-8433D2026-08-26
10198956461048CARDINAL HEALTHSOP18FTSTMSOP18FTSTM2026-08-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956476226CARDINAL HEALTHCardinal Health 200, LLCHIO2026-06-01
10198956418189CARDINAL HEALTHCardinal Health 200, LLCHIO2026-04-15
10198956345973CARDINAL HEALTHCardinal Health 200, LLCHIO2026-03-03
50198956345971CARDINAL HEALTHCardinal Health 200, LLCHIO2026-03-03
10198956309418CARDINAL HEALTHCardinal Health 200, LLCHIO2025-12-26
50198956309416CARDINAL HEALTHCardinal Health 200, LLCHIO2025-12-26
10198956251274CARDINAL HEALTHCardinal Health 200, LLCHIO2025-11-04
10198956224384CARDINAL HEALTHCardinal Health 200, LLCHIO2025-10-31
10198956063648CARDINAL HEALTHCardinal Health 200, LLCHIO2025-07-28
50198956063646CARDINAL HEALTHCardinal Health 200, LLCHIO2025-07-28
B098R404ROJFB0Aligned Medical SolutionsAligned Medical SolutionsHIO2025-03-17
B098R404ROJFB1Aligned Medical SolutionsAligned Medical SolutionsHIO2025-03-17
50197106799572CARDINAL HEALTHCardinal Health 200, LLCHIO2024-10-31
10197106781241CARDINAL HEALTHCardinal Health 200, LLCHIO2024-10-29
50197106781249CARDINAL HEALTHCardinal Health 200, LLCHIO2024-10-29
10197106784457CARDINAL HEALTHCardinal Health 200, LLCHIO2024-10-03
50197106784455CARDINAL HEALTHCardinal Health 200, LLCHIO2024-10-03
10197106704905CARDINAL HEALTHCardinal Health 200, LLCHIO2024-07-09
50197106704903CARDINAL HEALTHCardinal Health 200, LLCHIO2024-07-09
10197106602423CARDINAL HEALTHCardinal Health 200, LLCHIO2024-04-16
10197106615195CARDINAL HEALTHCardinal Health 200, LLCHIO2024-04-16
50197106602421CARDINAL HEALTHCardinal Health 200, LLCHIO2024-04-16
50197106615193CARDINAL HEALTHCardinal Health 200, LLCHIO2024-04-16
00191072215246ACSAMERICAN CONTRACT SYSTEMS, INC.HIO2024-01-12
10197106448694CARDINAL HEALTHCardinal Health 200, LLCHIO2023-12-19
50197106448692CARDINAL HEALTHCardinal Health 200, LLCHIO2023-12-19
00849233013766Busse Hospital DisposablesROBERT BUSSE & CO., INC.HIO2023-12-12
10849233013763Busse Hospital DisposablesROBERT BUSSE & CO., INC.HIO2023-12-12
05060259071300AmnicatorsMEDICAL WIRE & EQUIPMENT CO.(BATH)LIMITEDHIO2023-10-05
25060259071304AmnicatorsMEDICAL WIRE & EQUIPMENT CO.(BATH)LIMITEDHIO2023-10-05