Consulting Wallah › Device Explorer › IVD & laboratory › Non-evacuated urine specimen container IVD, no add
Device Explorer · FDA GUDID · GMDN 46023

Non-evacuated urine specimen container IVD, no additive

A covered plastic receptacle with no additives intended to be used for the collection, and preservation and/or transport, of a urine specimen for culture, analysis, and/or other investigation. This is a single-use device.

US‑registered devices80in commercial distribution
Companies11labelers on GUDID
Single‑use99%of device records
Sterile22%labelled sterile
Prescription10%Rx‑only share
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Share of device records

Sarstedt Aktiengesellschaft & Co.Kg3442%
Medegen Medical Products, Llc2835%
Mckesson Medical-Surgical Inc.56%
Hologic, Inc.45%
Diagnostics For The Real World Limited22%
Greiner Bio-One Gmbh22%
Sarstedt, Inc.11%
Lsl Industries, Llc11%

Top labelers

CompanyDevicesShare
Sarstedt Aktiengesellschaft & Co.Kg3442%
Medegen Medical Products, Llc2835%
Mckesson Medical-Surgical Inc.56%
Hologic, Inc.45%
Diagnostics For The Real World Limited22%
Greiner Bio-One Gmbh22%
Sarstedt, Inc.11%
Lsl Industries, Llc11%
Becton, Dickinson And Company11%
Simport Scientific Inc.11%
Henry Schein, Inc.11%

Company = labeler of record on GUDID. 11 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

urine cup 76x 60Urine cup NFT 100ml temp. lab8,5 ml Urine MonovetteUrine Container NFT 3.0lUrine cup NFT 100mlDisposable cup 100ml, PPUrine container 3.0 lTube 70ml 55x44PP+Cap100ml Disposable cup, PPTube 70ml, 55x44mm, PPUrine Monovette 8,5 mlUrine Monovette® 10ml opaqueUrine Monovette 10 mlUrine Monovette® 8.5mlUrine Monovette® 10mlUrine Monovette® 3.2ml

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

FDA product codes

CodeNameDevices
NNICONTAINER, SPECIMEN, NON-STERILE28
NNKCONTAINER, SPECIMEN MAILER AND STORAGE, NON-STERILE20
KDTCONTAINER, SPECIMEN MAILER AND STORAGE, STERILE8
NNIContainer, Specimen, Non-Sterile7
FMHCONTAINER, SPECIMEN, STERILE5
KDTContainer, Specimen Mailer And Storage, Sterile4

GMDN & GCC registration

  • GMDN code 46023 · non‑implantable
  • Single‑use 99% · sterile 22% · Rx‑only 10% · OTC 5%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Total Volume (Fluid Ounce) · 1

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

How many non-evacuated urine specimen container ivd, no additive products are registered in the US?

80 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Non-evacuated urine specimen container IVD, no additive", from 11 companies. The largest labeler is Sarstedt Aktiengesellschaft & Co.Kg with 42% of records.

Which FDA product codes apply?

NNI (CONTAINER, SPECIMEN, NON-STERILE), NNK (CONTAINER, SPECIMEN MAILER AND STORAGE, NON-STERILE), KDT (CONTAINER, SPECIMEN MAILER AND STORAGE, STERILE), NNI (Container, Specimen, Non-Sterile)

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.

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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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