FDA.reportPublic FDA data

Amniocentesis kit, non-medicated

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, and dressings. 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
71
Last updated
2026-08-08 10:08:23

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
10198956535381CARDINAL HEALTHCardinal Health 200, LLCPL45CPVH42026-07-27
00749756980418DeRoyalDEROYAL INDUSTRIES, INC.89-101232021-07-12
07350025912288Amniocentesis NeedleVitrolife Sweden AB148012016-09-09
10195594010072CARDINAL HEALTHCardinal Health 200, LLCPBMVLGN112021-04-12
10195594076603CARDINAL HEALTHCardinal Health 200, LLCSMA7CVHYN42021-05-10
10195594157470CARDINAL HEALTHCardinal Health 200, LLCSMA7CVHYN52021-06-18
10195594246327CARDINAL HEALTHCardinal Health 200, LLCSMA7CVHYN62021-08-13
10195594734923CARDINAL HEALTHCardinal Health 200, LLCSMA7CVHYNO2022-08-02
10195594942106CARDINAL HEALTHCardinal Health 200, LLCSAM34AMSPF2021-03-31
10197106478455CARDINAL HEALTHCardinal Health 200, LLCSMA7CVHYNP2023-11-09
10197106764725CARDINAL HEALTHCardinal Health 200, LLCSMA7CVHYNQ2024-09-24
10198956003019CARDINAL HEALTHCardinal Health 200, LLCSMA7CVHYN72025-03-20
10198956073265CARDINAL HEALTHCardinal Health 200, LLCSMA7CVHYN82025-05-13
10198956251274CARDINAL HEALTHCardinal Health 200, LLCSAM34AMSP12025-11-04
10198956345973CARDINAL HEALTHCardinal Health 200, LLC29-3485A2026-03-03
10198956446786CARDINAL HEALTHCardinal Health 200, LLCPL45CPVH12026-04-27
10198956457607CARDINAL HEALTHCardinal Health 200, LLCPL45CPVH22026-04-21
10885425145225CARDINAL HEALTHCardinal Health 200, LLCSBA32ATSVA2016-07-12
10885425852901CARDINAL HEALTHCardinal Health 200, LLCSAM34AMSPE2017-02-04
10885425992669CARDINAL HEALTHCardinal Health 200, LLC29-3240A2016-09-06
10887488293943CARDINAL HEALTHCardinal Health 200, LLCSMA12CSCUH2015-07-17
10887488314853CARDINAL HEALTHCardinal Health 200, LLCSMA7CVHYNI2015-08-31
10887488318295CARDINAL HEALTHCardinal Health 200, LLCSAM11SVHCC2016-07-07
10887488550169CARDINAL HEALTHCardinal Health 200, LLCSMA7CVHYNJ2016-10-21
10887488551463CARDINAL HEALTHCardinal Health 200, LLC29-8897A2016-07-19
10887488768830CARDINAL HEALTHCardinal Health 200, LLCSMA7CVHYNK2017-08-10
10888439125559CARDINAL HEALTHCardinal Health 200, LLCSMAOCAMWC32018-08-09
10888439168334CARDINAL HEALTHCardinal Health 200, LLCSAM55AMKW12018-09-06
10888439238228CARDINAL HEALTHCardinal Health 200, LLCSMA7CVHYN12018-10-22
10888439281941CARDINAL HEALTHCardinal Health 200, LLCSMA7CVHYN22018-11-19
10888439303957CARDINAL HEALTHCardinal Health 200, LLCSMA7CVHYN32018-12-11
10888439351309CARDINAL HEALTHCardinal Health 200, LLCSMA7CVHYNL2019-02-21
10888439533330CARDINAL HEALTHCardinal Health 200, LLCSMA7CVHYNM2019-07-01
10888439636222CARDINAL HEALTHCardinal Health 200, LLC29-3240B2020-04-23
10888439951417CARDINAL HEALTHCardinal Health 200, LLCSMA7CVHYNN2020-12-17
B09800634400Aligned Medical SolutionsAligned Medical Solutions00634402018-10-31
B09800949000Aligned Medical SolutionsAligned Medical Solutions00949002018-11-01
B098AM444TJA0Aligned Medical SolutionsAligned Medical SolutionsAM444TJA2018-11-01
B098AMS36870Aligned Medical SolutionsAligned Medical SolutionsAMS36872018-11-01
B098PSS2166B0Aligned Medical SolutionsAligned Medical SolutionsPSS2166B2018-11-14
B098PSS29050Aligned Medical SolutionsAligned Medical SolutionsPSS29052018-11-14
B098R404ROJFA0Aligned Medical SolutionsAligned Medical SolutionsR404ROJFA2018-11-14
B098R404ROJFB0Aligned Medical SolutionsAligned Medical SolutionsR404ROJFB2025-03-17
50198956345971CARDINAL HEALTHCardinal Health 200, LLC29-3485A2026-03-03
50198956073263CARDINAL HEALTHCardinal Health 200, LLCSMA7CVHYN82025-05-13
50198956003017CARDINAL HEALTHCardinal Health 200, LLCSMA7CVHYN72025-03-20
B098R404ROJFB1Aligned Medical SolutionsAligned Medical SolutionsR404ROJFB2025-03-17
50197106764723CARDINAL HEALTHCardinal Health 200, LLCSMA7CVHYNQ2024-09-24
50197106478453CARDINAL HEALTHCardinal Health 200, LLCSMA7CVHYNP2023-11-09
50195594734921CARDINAL HEALTHCardinal Health 200, LLCSMA7CVHYNO2022-08-02
50195594246325CARDINAL HEALTHCardinal Health 200, LLCSMA7CVHYN62021-08-13
50749756980413DeRoyalDEROYAL INDUSTRIES, INC.89-101232021-07-12
50195594157478CARDINAL HEALTHCardinal Health 200, LLCSMA7CVHYN52021-06-18
50195594076601CARDINAL HEALTHCardinal Health 200, LLCSMA7CVHYN42021-05-10
50195594010070CARDINAL HEALTHCardinal Health 200, LLCPBMVLGN112021-04-12
50195594942104CARDINAL HEALTHCardinal Health 200, LLCSAM34AMSPF2021-03-31
50888439951415CARDINAL HEALTHCardinal Health 200, LLCSMA7CVHYNN2020-12-17
50888439636220CARDINAL HEALTHCardinal Health 200, LLC29-3240B2020-04-23
50888439533338CARDINAL HEALTHCardinal Health 200, LLCSMA7CVHYNM2019-07-01
50888439281949CARDINAL HEALTHCardinal Health 200, LLCSMA7CVHYN22018-11-19
50888439303955CARDINAL HEALTHCardinal Health 200, LLCSMA7CVHYN32018-12-11
50888439351307CARDINAL HEALTHCardinal Health 200, LLCSMA7CVHYNL2019-02-21
B09800634401Aligned Medical SolutionsAligned Medical Solutions00634402018-10-31
B09800949001Aligned Medical SolutionsAligned Medical Solutions00949002018-11-01
B098AM444TJA1Aligned Medical SolutionsAligned Medical SolutionsAM444TJA2018-11-01
B098AMS36871Aligned Medical SolutionsAligned Medical SolutionsAMS36872018-11-01
B098PSS2166B1Aligned Medical SolutionsAligned Medical SolutionsPSS2166B2018-11-14
B098PSS29051Aligned Medical SolutionsAligned Medical SolutionsPSS29052018-11-14
B098R404ROJFA1Aligned Medical SolutionsAligned Medical SolutionsR404ROJFA2018-11-14
17350025912285Amniocentesis NeedleVitrolife Sweden AB148012016-09-09
07350025915531Amniocentesis NeedleVitrolife Sweden AB178012018-01-09