FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10197106615195
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
29-0115C
Catalog number
29-0115C
Device description
AMNIOCENTESIS PACK
Published
2024-04-16
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
50197106615193PackageGS124In Commercial Distribution
10197106615195PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710661519350197106615193
1019710661519510197106615195

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 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
10197106911266CARDINAL HEALTHSBA60POLHCSBA60POLHC2026-06-08
10197106983577CARDINAL HEALTHSEN69ERMVDSEN69ERMVD2026-06-08
10198956182264CARDINAL HEALTHSCV43OOTGKSCV43OOTGK2026-06-08
10198956218611CARDINAL HEALTHSOP55AOKFJSOP55AOKFJ2026-06-08
10198956227552CARDINAL HEALTHSEY33EPCAFSEY33EPCAF2026-06-08
10198956279391CARDINAL HEALTH01-0111A01-0111A2026-06-08
10198956312920CARDINAL HEALTHSMA57CESARSMA57CESAR2026-06-08
10198956332096CARDINAL HEALTHSOP32THGMLSOP32THGML2026-06-08
10198956336865CARDINAL HEALTHPN73CRKPBPN73CRKPB2026-06-08
10198956343139CARDINAL HEALTHSOP45HAOCCSOP45HAOCC2026-06-08
10198956359024CARDINAL HEALTHSBA24UPJRGSBA24UPJRG2026-06-08
10198956362932CARDINAL HEALTHSEN48TASABSEN48TASAB2026-06-08
10198956364349CARDINAL HEALTHSBACGRPGRASBACGRPGRA2026-06-08
10198956364783CARDINAL HEALTHSNE38LMCIBSNE38LMCIB2026-06-08
10198956373372CARDINAL HEALTHSOP31EXHNGSOP31EXHNG2026-06-08
10198956373976CARDINAL HEALTHSOP38SHUSHSOP38SHUSH2026-06-08
10198956374119CARDINAL HEALTHSBA56LPSTCSBA56LPSTC2026-06-08
10198956386150CARDINAL HEALTHSEN69SPREBSEN69SPREB2026-06-08
10198956387171CARDINAL HEALTHSBA41PLRSESBA41PLRSE2026-06-08
10198956390430CARDINAL HEALTHSEN37TSPSDSEN37TSPSD2026-06-08

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
10197106799574CARDINAL HEALTHCardinal Health 200, LLCHIO2024-10-31
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
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