FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10195594045418
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
29-5092A
Catalog number
29-5092A
Device description
AMINOCENTESIS TRAY
Published
2021-05-20
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
50195594045416PackageGS148In Commercial Distribution
10195594045418PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019559404541650195594045416
1019559404541810195594045418

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
10192253067958Dover200620062026-01-15
10192253067965Dover61536153-2026-01-15
10192253067972Dover61546154-2026-01-15
10192253067989Dover812281222026-01-15
10192253067996Dover888760078488876007842026-01-15
10192253068009Dover89498949-2026-01-15
10192253068016Dover895089502026-01-15
10192253068702Dover888760077688876007762026-01-16
10192253071405CARDINAL HEALTHALMASK5ALMASK52026-04-06
10192253071412CARDINAL HEALTHAMMASK4AMMASK42026-03-23
10192253071429CARDINAL HEALTHAXLMASK6AXLMASK62026-03-23
10192253071436CARDINAL HEALTHCHIMASK3CHIMASK32026-03-23
10192253071443CARDINAL HEALTHINFMASK1INFMASK12026-03-23
10192253071450CARDINAL HEALTHNEOMASK0NEOMASK02026-03-23
10192253071467CARDINAL HEALTHTODMASK2TODMASK22026-03-23
10192253006278Genius3030963030962024-02-28
10192253006285Genius3030973030972024-02-28
10192253047486Telfa766776672025-09-08
10197106917619CARDINAL HEALTHPC15OT92CPC15OT92C2026-07-20
10198956119505CARDINAL HEALTHSVA35VCBLCSVA35VCBLC2026-07-20

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
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