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Device Explorer · FDA GUDID · GMDN 58977

Basic intravenous administration set, noninvasive

A collection of noninvasive devices intended to conduct fluids from an intravenous (IV) administration bag/bottle to a peripheral venous cannula (not included) during gravitational or pump administration to a patient's venous system; some types may in addition

US‑registered devices5,249in commercial distribution
Companies62labelers on GUDID
Single‑use100%of device records
Sterile99%labelled sterile
Prescription39%Rx‑only share
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Share of device records

Icu Medical, Inc.3,03258%
Merit Medical Systems, Inc.3837%
B. Braun Medical Inc.3296%
Codan Us Corporation2405%
Medline Industries, Inc.2184%
Amsino International, Inc.1202%
Bd Switzerland Sàrl1162%
Centurion Medical Products Corporation1122%

Top labelers

CompanyDevicesShare
Icu Medical, Inc.3,03258%
Merit Medical Systems, Inc.3837%
B. Braun Medical Inc.3296%
Codan Us Corporation2405%
Medline Industries, Inc.2184%
Amsino International, Inc.1202%
Bd Switzerland Sàrl1162%
Centurion Medical Products Corporation1122%
U.S. Infusion, Llc691%
Trinity Sterile, Inc.641%
Baxter Healthcare Corporation591%
Navilyst Medical, Inc.461%

Company = labeler of record on GUDID. 62 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Alaris, SmartSiteBD SmartSiteAlarisNfuzeMcGuffIMEDRight Way MedicalIV ADD-ON FILTER ADMINISTRATION SET WITH .22 MICIV ADMINISTRATION SET WITH .22 MICRON FILTERIV ADMINISTRATION SET SECONDARY ADMINISTRATION SIV ADMINISTRATION SET WITH NEEDLELESS ACCESS CONIV ADMINISTRATION SETAnesthesia IV SetIV Administration SetSAFEPORT™Extension Set

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

FDA product codes

CodeNameDevices
FMGStopcock, i.V. Set2,787
FPASet, administration, intravascular1,324
FPASet, Administration, Intravascular719
OJAIntravenous extension tubing set338
LRSI.V. start kit261
ONBClosed antineoplastic and hazardous drug reconstitution and 67

GMDN & GCC registration

  • GMDN code 58977 · non‑implantable
  • Single‑use 100% · sterile 99% · Rx‑only 39% · 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

Length (Inch) · 261Outer Diameter (Millimeter) · 6Total Volume (Milliliter) · 6Length (Millimeter) · 5Lumen/Inner Diameter (Millimeter) · 5Length (Centimeter) · 2

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

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

5,249 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Basic intravenous administration set, noninvasive", from 62 companies. The largest labeler is Icu Medical, Inc. with 58% of records.

Which FDA product codes apply?

FMG (Stopcock, i.V. Set), FPA (Set, administration, intravascular), FPA (Set, Administration, Intravascular), OJA (Intravenous extension tubing set)

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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