Consulting Wallah › Device Explorer › Syringes, needles & infusion › Ambulatory insulin infusion pump, electronic, non-
Device Explorer · FDA GUDID · GMDN 64889

Ambulatory insulin infusion pump, electronic, non-software-dosing

A portable electronic device designed to provide continuous or intermittent subcutaneous delivery of insulin to a patient with diabetes mellitus; it does not include insulin dosage determining software. It may be badge-like, designed to adhere to skin or cloth

US‑registered devices621in commercial distribution
Companies3labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription100%Rx‑only share
ShareLinkedIn

Share of device records

Medtronic Minimed, Inc.61599%
Modular Medical, Inc.51%
Sooil Development Co.,Ltd10%

Top labelers

CompanyDevicesShare
Medtronic Minimed, Inc.61599%
Modular Medical, Inc.51%
Sooil Development Co.,Ltd10%

Company = labeler of record on GUDID. 3 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

PARADIGM® REAL-timePIVOT Insulin Pump Starter KitMODD1 Patient Welcome KitMODD1 Starter KitMODD1 PumpPIVOT Insulin Pump ReplacementParadigm® REAL-Time Revel™Paradigm® REAL-TimeParadigm®MiniMed ® ConnectParadigm Real-Time Revel Insulin Pump With EnlitDANA Diabecare

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

FDA product codes

CodeNameDevices
MDSSensor, glucose, invasive613
OYCPump, infusion, insulin, to be used with invasive glucose se16
LZGPump, Infusion, Insulin6
LZGPump, infusion, insulin3
KZHIntroducer, Syringe Needle2
PKUInsulin pump secondary display1

GMDN & GCC registration

  • GMDN code 64889 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 100% · 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

No structured size data on the register.

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

How many ambulatory insulin infusion pump, electronic, non-software-dosing products are registered in the US?

621 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Ambulatory insulin infusion pump, electronic, non-software-dosing", from 3 companies. The largest labeler is Medtronic Minimed, Inc. with 99% of records.

Which FDA product codes apply?

MDS (Sensor, glucose, invasive), OYC (Pump, infusion, insulin, to be used with invasive glucose se), LZG (Pump, Infusion, Insulin), LZG (Pump, infusion, insulin)

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?

Add ambulatory insulin infusion pump, electronic, non-software-dosing to the RFQ basket or use the form below with quantity, specification and delivery location; the Network returns comparable quotes from verified suppliers in 2–5 working days.

Request quotes for Ambulatory insulin infusion pump, electronic, non-software-dosing

Hospitals, pharmacies and distributors anywhere: tell us what you need and the Consulting Wallah Network returns comparable quotes from verified suppliers. No fee for buyers.

Buying ambulatory insulin infusion pump, electronic, non- for a hospital group?Free executive assessment: we benchmark your prices and tender structure against the Network.
Book the free assessment

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.

Get quotes →