A covered plastic receptacle with no additives intended to be used for the collection, and preservation and/or transport, of a midstream urine specimen for analysis and/or other investigation. The midstream is collected after an initial pre-measured volume of
| Company | Devices | Share |
|---|---|---|
| Cardinal Health 200, Llc | 21 | 38% |
| Bioseal | 11 | 20% |
| Medical Action Industries Inc. | 10 | 18% |
| Cardinal Health, Inc. | 8 | 15% |
| Starplex Scientific Corp. | 2 | 4% |
| Rocket Medical Plc | 1 | 2% |
| Medegen Medical Products, Llc | 1 | 2% |
| Medline Industries, Inc. | 1 | 2% |
Company = labeler of record on GUDID. 8 companies in total; top 12 shown. Click headers to sort.
Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.
| Code | Name | Devices |
|---|---|---|
| FMH | CONTAINER, SPECIMEN, STERILE | 55 |
| OIE | Urine collection kit (excludes HIV testing) | 17 |
| FCN | Urinary drainage collection kit, for indwelling catheter | 9 |
| FMH | Container, Specimen, Sterile | 5 |
| MDM | INSTRUMENT, MANUAL, SURGICAL, GENERAL USE | 4 |
| FFG | DEVICE, URINE FLOW RATE MEASURING, NON-ELECTRICAL, DISPOSABL | 3 |
Use these as the dimensions to specify in a tender line.
No closely related category with 50+ devices.
55 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Midstream urine specimen container IVD", from 8 companies. The largest labeler is Cardinal Health 200, Llc with 38% of records.
FMH (CONTAINER, SPECIMEN, STERILE), OIE (Urine collection kit (excludes HIV testing)), FCN (Urinary drainage collection kit, for indwelling catheter), FMH (Container, Specimen, Sterile)
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.