FDA.reportPublic FDA data

Amniocentesis kit, medicated, single-use

Definition
A 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.
GUDID devices
134
Last updated
2026-06-11 06:05:43

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
10198956476226CARDINAL HEALTHCardinal Health 200, LLC29-1394B2026-06-01
00685404000445Sterling Medical Products APOLLO MEDICAL PRODUCTS CORP.11062019-09-03
00849233008823Busse Hospital DisposablesROBERT BUSSE & CO., INC.650B2022-11-14
00849233013766Busse Hospital DisposablesROBERT BUSSE & CO., INC.9762023-12-12
00886333220793Amniocentesis TrayARGON MEDICAL DEVICES, INC.A4545A2022-07-20
00886333220809Amniocentesis TrayARGON MEDICAL DEVICES, INC.A4545ASP2022-07-20
00886333224302Amniocentesis TrayARGON MEDICAL DEVICES, INC.A4545ALF2022-07-20
10195594035112CARDINAL HEALTHCardinal Health 200, LLC29-0083C2021-04-27
10195594045418CARDINAL HEALTHCardinal Health 200, LLC29-5092A2021-05-20
10195594070274CARDINAL HEALTHCardinal Health 200, LLC29-0083D2021-08-26
10195594111946CARDINAL HEALTHCardinal Health 200, LLCSMA12GL38C2021-06-16
10195594127817CARDINAL HEALTHCardinal Health 200, LLCSMA12GL38D2021-08-26
10195594399108CARDINAL HEALTHCardinal Health 200, LLCSMA12GL3812021-10-25
10195594409036CARDINAL HEALTHCardinal Health 200, LLC29-1077A2021-11-30
10195594425470CARDINAL HEALTHCardinal Health 200, LLCSMA12GL3822021-11-12
10195594623951CARDINAL HEALTHCardinal Health 200, LLCSMA12GL3832022-04-06
10195594853334CARDINAL HEALTHCardinal Health 200, LLCSMA12GL3842022-09-29
10195594909895CARDINAL HEALTHCardinal Health 200, LLCSMA12GL38B2021-03-10
10197106089002CARDINAL HEALTHCardinal Health 200, LLC29-2088B2023-02-24
10197106421406CARDINAL HEALTHCardinal Health 200, LLC29-0083E2023-09-08
10197106448694CARDINAL HEALTHCardinal Health 200, LLC29-0083F2023-12-19
10197106602423CARDINAL HEALTHCardinal Health 200, LLC29-1077B2024-04-16
10197106615195CARDINAL HEALTHCardinal Health 200, LLC29-0115C2024-04-16
10197106673461CARDINAL HEALTHCardinal Health 200, LLCSMA12GL3852024-05-23
10197106704905CARDINAL HEALTHCardinal Health 200, LLC29-0083G2024-07-09
10197106784457CARDINAL HEALTHCardinal Health 200, LLC29-0083J2024-10-03
10197106799574CARDINAL HEALTHCardinal Health 200, LLC29-0083K2024-10-31
10198956063648CARDINAL HEALTHCardinal Health 200, LLC29-0083L2025-07-28
10198956224384CARDINAL HEALTHCardinal Health 200, LLC29-6526A2025-10-31
10198956238299CARDINAL HEALTHCardinal Health 200, LLCSMA12GL3862025-11-17
10198956309418CARDINAL HEALTHCardinal Health 200, LLCSAN94AMDV22025-12-26
10198956326194CARDINAL HEALTHCardinal Health 200, LLCSMA12GL38E2026-02-09
10198956418189CARDINAL HEALTHCardinal Health 200, LLC29-4038A2026-04-15
10809160019160Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.738392016-08-20
10884521020412CurityCardinal Health, Inc.970512018-06-30
10885403057120N/ACAREFUSION 2200, INC4545A2016-09-23
10885403108150Safe-TCAREFUSION 2200, INC4545ASP2016-09-23
10885425210107CARDINAL HEALTHCardinal Health 200, LLC29-AM1CO2016-08-17
10885425210114CARDINAL HEALTHCardinal Health 200, LLC29-AM1SF2016-07-18
10885425598564CARDINAL HEALTHCardinal Health 200, LLCSMAOCAMWCD2017-01-20
10885425665457CARDINAL HEALTHCardinal Health 200, LLC29-53842016-08-17
10885425836758CARDINAL HEALTHCardinal Health 200, LLC29-1538D2016-08-07
10885425983773CARDINAL HEALTHCardinal Health 200, LLCSAM55AMKWF2016-11-26
10887488027876CARDINAL HEALTHCardinal Health 200, LLC29-20882016-09-27
10887488030630CARDINAL HEALTHCardinal Health 200, LLC29-38672016-07-08
10887488121147CARDINAL HEALTHCardinal Health 200, LLC29-56892016-10-17
10887488293578CARDINAL HEALTHCardinal Health 200, LLC29-AM2CO2017-08-22
10887488293585CARDINAL HEALTHCardinal Health 200, LLC29-AM2CODF2016-08-02
10887488293608CARDINAL HEALTHCardinal Health 200, LLC29-AM1CODF2016-08-02
10887488462110CARDINAL HEALTHCardinal Health 200, LLCSLC12GLUVZ2016-08-07
10887488508481CARDINAL HEALTHCardinal Health 200, LLCSAMOCAMFHG2016-06-30
10887488514789CARDINAL HEALTHCardinal Health 200, LLCSAM11ATNSH2016-08-15
10887488515335CARDINAL HEALTHCardinal Health 200, LLC29-0083A2016-07-12
10887488523897CARDINAL HEALTHCardinal Health 200, LLCSAM33AMMCE2016-08-11
10887488524771CARDINAL HEALTHCardinal Health 200, LLCSAM94AMDVG2016-07-01
10887488525136CARDINAL HEALTHCardinal Health 200, LLC29-1938A2016-09-03
10887488529240CARDINAL HEALTHCardinal Health 200, LLC30A0307A2016-06-30
10887488588919CARDINAL HEALTHCardinal Health 200, LLC29-0115A2016-09-26
10887488637761CARDINAL HEALTHCardinal Health 200, LLC29-5301A2016-12-19
10887488639604CARDINAL HEALTHCardinal Health 200, LLCSLC12GL38A2017-01-06
10887488643885CARDINAL HEALTHCardinal Health 200, LLC09-3867A2016-12-29
10887488710754CARDINAL HEALTHCardinal Health 200, LLC29-5384A2017-03-31
10887488741734CARDINAL HEALTHCardinal Health 200, LLC29-3031D2017-07-17
10887488883113CARDINAL HEALTHCardinal Health 200, LLCSAM33AMMC12017-12-14
10887488885728CARDINAL HEALTHCardinal Health 200, LLCSLC12GL38B2018-01-08
10887488887074CARDINAL HEALTHCardinal Health 200, LLC29-2088A2017-12-26
10887488938011CARDINAL HEALTHCardinal Health 200, LLC09-3867B2018-03-16
10887488941554CARDINAL HEALTHCardinal Health 200, LLCSAM33AMMC22018-03-15
10887488958668CARDINAL HEALTHCardinal Health 200, LLCSAM33AMMC32018-04-13
10888439079524CARDINAL HEALTHCardinal Health 200, LLCSAMOCAMFHH2018-09-05
10888439098136CARDINAL HEALTHCardinal Health 200, LLCSMAOCAMWC22018-08-06
10888439113327CARDINAL HEALTHCardinal Health 200, LLC30A0307C2018-09-06
10888439275162CARDINAL HEALTHCardinal Health 200, LLCSAM33AMMC42018-11-20
10888439365719CARDINAL HEALTHCardinal Health 200, LLC29-5301B2019-03-06
10888439380910CARDINAL HEALTHCardinal Health 200, LLC30A0307D2019-02-19
10888439459821CARDINAL HEALTHCardinal Health 200, LLC29-2808A2019-06-11
10888439514100CARDINAL HEALTHCardinal Health 200, LLC30A0307E2019-07-09
10888439632811CARDINAL HEALTHCardinal Health 200, LLC29-2808B2020-05-27
10888439641059CARDINAL HEALTHCardinal Health 200, LLCSAM33AMMCF2020-04-30
10888439845518CARDINAL HEALTHCardinal Health 200, LLC29-1815A2020-07-20