Consulting Wallah › Device Explorer › Procedure kits & trays › Amniocentesis kit, medicated, single-use
Device Explorer · FDA GUDID · GMDN 35496

Amniocentesis kit, medicated, single-use

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, d

US‑registered devices79in commercial distribution
Companies5labelers on GUDID
Single‑use100%of device records
Sterile100%labelled sterile
Prescription99%Rx‑only share
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Share of device records

Cardinal Health 200, Llc7494%
Robert Busse & Co., Inc.23%
Apollo Medical Products Corp.11%
Aligned Medical Solutions11%
Medical Action Industries Inc.11%

Top labelers

CompanyDevicesShare
Cardinal Health 200, Llc7494%
Robert Busse & Co., Inc.23%
Apollo Medical Products Corp.11%
Aligned Medical Solutions11%
Medical Action Industries Inc.11%

Company = labeler of record on GUDID. 5 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Busse Hospital DisposablesSterling Medical ProductsAligned Medical SolutionsCARDINAL HEALTHMedical Action Industries

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
HIOSampler, amniotic fluid (amniocentesis tray)44
HIOSAMPLER, AMNIOTIC FLUID (AMNIOCENTESIS TRAY)18
OHDGynecological laparoscopic kit15
HIOSampler, Amniotic Fluid (Amniocentesis Tray)5
OJTAspiration tray1
GAANEEDLE, ASPIRATION AND INJECTION, DISPOSABLE1

GMDN & GCC registration

  • GMDN code 35496 · non‑implantable
  • Single‑use 100% · sterile 100% · Rx‑only 99% · OTC 0%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

No structured size data on the register.

Use these as the dimensions to specify in a tender line.

No closely related category with 50+ devices.

How many amniocentesis kit, medicated, single-use products are registered in the US?

79 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Amniocentesis kit, medicated, single-use", from 5 companies. The largest labeler is Cardinal Health 200, Llc with 94% of records.

Which FDA product codes apply?

HIO (Sampler, amniotic fluid (amniocentesis tray)), HIO (SAMPLER, AMNIOTIC FLUID (AMNIOCENTESIS TRAY)), OHD (Gynecological laparoscopic kit), HIO (Sampler, Amniotic Fluid (Amniocentesis Tray))

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

How do I get quotes?

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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