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Device Explorer · FDA GUDID · GMDN 47903

Infusion pump medication-dosage application software

A software program intended to enable a healthcare professional to create, modify and store (manage) dosage parameters (protocols) for delivery of medication by an electronic infusion pump(s) or a syringe pump(s) which is used in a hospital/institution (e.g.,

US‑registered devices77in commercial distribution
Companies7labelers on GUDID
Single‑use3%of device records
Sterile0%labelled sterile
Prescription75%Rx‑only share
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Share of device records

Icu Medical, Inc.4964%
Carefusion 303, Inc.1013%
Fresenius Kabi Ag912%
Monarch Medical Technologies Llc45%
Baxter Healthcare Corporation34%
Glytec, Llc11%
Iradimed Corp.11%

Top labelers

CompanyDevicesShare
Icu Medical, Inc.4964%
Carefusion 303, Inc.1013%
Fresenius Kabi Ag912%
Monarch Medical Technologies Llc45%
Baxter Healthcare Corporation34%
Glytec, Llc11%
Iradimed Corp.11%

Company = labeler of record on GUDID. 7 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Vigilant Drug'Lib AGILIA USVigilant Software SuiteLifeShield Infusion Safety Software SuiteLifeShield Infusion Safety Software Suite - LifeGlucommanderEndoTool IVEndoTool SubQEndoToolIradimedIvenix Infusion SystemMedfusionCADDDOSE IQ SAFETY SOFTWAREPharmGuardMEDFUSIONICU Medical MedNet

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

FDA product codes

CodeNameDevices
FRNPump, infusion32
MRZACCESSORIES, PUMP, INFUSION26
PHCInfusion safety management software23
PHCInfusion Safety Management Software9
MEAPump, infusion, pca9
NDCCalculator, Drug Dose5

GMDN & GCC registration

  • GMDN code 47903 · non‑implantable
  • Single‑use 3% · sterile 0% · Rx‑only 75% · 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

Outer Diameter (Millimeter) · 1Length (Millimeter) · 1Width (Millimeter) · 1Circumference (Millimeter) · 1Depth (Millimeter) · 1

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

How many infusion pump medication-dosage application software products are registered in the US?

77 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Infusion pump medication-dosage application software", from 7 companies. The largest labeler is Icu Medical, Inc. with 64% of records.

Which FDA product codes apply?

FRN (Pump, infusion), MRZ (ACCESSORIES, PUMP, INFUSION), PHC (Infusion safety management software), PHC (Infusion Safety Management Software)

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.

How do I get quotes?

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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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