Consulting Wallah › Device Explorer › Syringes, needles & infusion › Bedside infusion pump, single-channel
Device Explorer · FDA GUDID · GMDN 13215

Bedside infusion pump, single-channel

An electrically-powered, non-ambulatory (bedside) device designed to facilitate the accurate and consistent administration of a single drug/solution which can be delivered via intravenous, subcutaneous, arterial, epidural, and intracavital routes using a dedic

US‑registered devices177in commercial distribution
Companies21labelers on GUDID
Single‑use8%of device records
Sterile6%labelled sterile
Prescription95%Rx‑only share
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Share of device records

Icu Medical, Inc.6436%
Carefusion 303, Inc.169%
Eitan Medical Ltd148%
Bayer Medical Care Inc.148%
B. Braun Medical Inc.127%
Nouvag Ag106%
Fresenius Kabi Ag95%
Baxter Healthcare Corporation74%

Top labelers

CompanyDevicesShare
Icu Medical, Inc.6436%
Carefusion 303, Inc.169%
Eitan Medical Ltd148%
Bayer Medical Care Inc.148%
B. Braun Medical Inc.127%
Nouvag Ag106%
Fresenius Kabi Ag95%
Baxter Healthcare Corporation74%
Emed Technologies Corporation53%
Hk Surgical Inc.53%
Zyno Medical Llc42%
Stockert Gmbh32%

Company = labeler of record on GUDID. 21 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Sapphire Multi-Pump Mounting DeviceCool Point™Novum IQINTELLAGEN™ Irrigation PumpINTELLAGEN™ Irrigation Pump KitSmartAblateTM System Irrigation PumpAGILIA VP MC WIFI USVOLUMAT MC AGILIA USInfusomat®Vista®Outlook®MD ResourceIradimedPOWER INFUSERTetra MicroHK Klein Infiltration Pump+

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

FDA product codes

CodeNameDevices
FRNPump, Infusion134
FRNPump, infusion100
MEAPump, Infusion, Pca54
MEAPump, infusion, pca17
FPASet, administration, intravascular16
PYRNeuraxial Administration Set - Intrathecal delivery8

GMDN & GCC registration

  • GMDN code 13215 · non‑implantable
  • Single‑use 8% · sterile 6% · Rx‑only 95% · 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) · 22Height (Inch) · 10Depth (Inch) · 10

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

How many bedside infusion pump, single-channel products are registered in the US?

177 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Bedside infusion pump, single-channel", from 21 companies. The largest labeler is Icu Medical, Inc. with 36% of records.

Which FDA product codes apply?

FRN (Pump, Infusion), FRN (Pump, infusion), MEA (Pump, Infusion, Pca), MEA (Pump, infusion, pca)

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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