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Device Explorer · FDA GUDID · GMDN 65416

Basic intravenous administration set, invasive

A collection of devices which includes a hypodermic needle (e.g., venous butterfly/scalp vein needle) intended to conduct fluids from an intravenous (IV) fluid container to a patient's venous system during administration; it may also be used for blood collecti

US‑registered devices119in commercial distribution
Companies15labelers on GUDID
Single‑use100%of device records
Sterile92%labelled sterile
Prescription90%Rx‑only share
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Share of device records

Greiner Bio-One Gmbh3832%
Terumo Medical Products (Hangzhou) Co., Ltd.2824%
Terumo Corporation1210%
Terumo Europe Nv98%
Anhui Kangda Medical Products Co.,Ltd.87%
Sb-Kawasumi Laboratories, Inc.65%
Salvin Dental Specialties, Llc43%
Sol-Millennium Medical, Inc.33%

Top labelers

CompanyDevicesShare
Greiner Bio-One Gmbh3832%
Terumo Medical Products (Hangzhou) Co., Ltd.2824%
Terumo Corporation1210%
Terumo Europe Nv98%
Anhui Kangda Medical Products Co.,Ltd.87%
Sb-Kawasumi Laboratories, Inc.65%
Salvin Dental Specialties, Llc43%
Sol-Millennium Medical, Inc.33%
Medivena, Llc33%
Bound Tree Medical, Llc22%
Aero-Med, Llc22%
Innovative Medical Technologies, Inc.11%

Company = labeler of record on GUDID. 15 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

baixinBAIXINSURFLOSURFLO™K-SHIELD ADVANTAGE SMALL VEIN INFUSION SETULTRAFLO-PBSalvin Dental SpecialtiesBIO-PRFSOL-CARE™ Safety Winged Infusion SetCuraplex®Aero-MedONE-CARE PRESS & LOCK Safety Blood Collection WiAdministration SetCAINASURSHIELDVacuette

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

FDA product codes

CodeNameDevices
FPASet, Administration, Intravascular59
FMINeedle, hypodermic, single lumen39
FPASet, administration, intravascular26
LRSI.V. start kit4
JKATubes, vials, systems, serum separators, blood collection3
LRPTRAY, SURGICAL2

GMDN & GCC registration

  • GMDN code 65416 · non‑implantable
  • Single‑use 100% · sterile 92% · Rx‑only 90% · OTC 2%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Needle Gauge (Gauge) · 62Length (Inch) · 43Total Volume (Milliliter) · 40Pore Size (Micrometer) · 3Length (Millimeter) · 3

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

How many basic intravenous administration set, invasive products are registered in the US?

119 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Basic intravenous administration set, invasive", from 15 companies. The largest labeler is Greiner Bio-One Gmbh with 32% of records.

Which FDA product codes apply?

FPA (Set, Administration, Intravascular), FMI (Needle, hypodermic, single lumen), FPA (Set, administration, intravascular), LRS (I.V. start kit)

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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