A sterile, sharp bevel-edged, hollow tubular metal instrument intended to be attached to a syringe and designed for the therapeutic injection or infusion of medicinal substances directly beneath the skin layer. This is a single-use device.
| Company | Devices | Share |
|---|---|---|
| Repro Med Systems, Inc. | 76 | 26% |
| Perouse Medical | 72 | 25% |
| Primrose Medical Inc | 33 | 11% |
| Exel International | 25 | 9% |
| Icu Medical, Inc. | 18 | 6% |
| Home Aide Diagnostics, Inc. | 15 | 5% |
| Aesthetic Group | 13 | 4% |
| Cook Biodevice Llc | 13 | 4% |
| Cook Incorporated | 9 | 3% |
| Unomedical A/S | 6 | 2% |
| Progressive Medical, Inc. | 4 | 1% |
| Baxalta Us Inc. | 3 | 1% |
Company = labeler of record on GUDID. 15 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 |
|---|---|---|
| FPA | Set, administration, intravascular | 80 |
| FMI | Needle, hypodermic, single lumen | 75 |
| FPA | Set, Administration, Intravascular | 62 |
| FMI | Needle, Hypodermic, Single Lumen | 33 |
| LJT | PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR | 22 |
| FOZ | Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 D | 18 |
Use these as the dimensions to specify in a tender line.
291 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Subcutaneous infusion/injection port needle", from 15 companies. The largest labeler is Repro Med Systems, Inc. with 26% of records.
FPA (Set, administration, intravascular), FMI (Needle, hypodermic, single lumen), FPA (Set, Administration, Intravascular), FMI (Needle, Hypodermic, Single Lumen)
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.