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Device Explorer · FDA GUDID · GMDN 35833

Electric infusion pump administration set, single-use

A collection of sterile devices (e.g., plastic tubing, check valve, roller clamp, Y-site connector, Luer, needle/catheter) intended to be used in combination with an electrically-powered infusion pump for the intravenous (IV), subcutaneous, intramuscular, or e

US‑registered devices1,361in commercial distribution
Companies30labelers on GUDID
Single‑use99%of device records
Sterile96%labelled sterile
Prescription97%Rx‑only share
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Share of device records

Bd Switzerland Sàrl27420%
Icu Medical, Inc.25819%
Unomedical A/S21716%
B. Braun Medical Inc.1209%
Norfolk Medical1027%
Eitan Medical Ltd826%
Summit Medical Products, Inc.463%
Fresenius Kabi Ag403%

Top labelers

CompanyDevicesShare
Bd Switzerland Sàrl27420%
Icu Medical, Inc.25819%
Unomedical A/S21716%
B. Braun Medical Inc.1209%
Norfolk Medical1027%
Eitan Medical Ltd826%
Summit Medical Products, Inc.463%
Fresenius Kabi Ag403%
Zyno Medical Llc332%
Zevex International, Inc.302%
Avanos Medical, Inc.282%
Laborie Medical Technologies Canada Ulc272%

Company = labeler of record on GUDID. 30 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Alaris, SmartSiteAlarisAlaris, VersaSafeMedSystem III, SmartSiteSmartSiteAlaris, Signature EditionAlaris, Signature Edition, SmartSiteSoft-Release-MicroOrbit softSoft-Release-OiLet FlexInset IIinset™Autosoft XCMedtronic Extendedcontact detach

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, Intravascular860
FPASet, administration, intravascular842
LHISet, i.V. Fluid transfer145
FRNPump, Infusion78
FRNPump, infusion39
MRZACCESSORIES, PUMP, INFUSION39

GMDN & GCC registration

  • GMDN code 35833 · non‑implantable
  • Single‑use 99% · sterile 96% · Rx‑only 97% · 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

Angle (degree) · 598Depth (Millimeter) · 594Length (Centimeter) · 581Length (Inch) · 383Needle Gauge (Gauge) · 98Length (Millimeter) · 15

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

How many electric infusion pump administration set, single-use products are registered in the US?

1,361 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Electric infusion pump administration set, single-use", from 30 companies. The largest labeler is Bd Switzerland Sàrl with 20% of records.

Which FDA product codes apply?

FPA (Set, Administration, Intravascular), FPA (Set, administration, intravascular), LHI (Set, i.V. Fluid transfer), FRN (Pump, Infusion)

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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