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Device Explorer · FDA GUDID · GMDN 64891

Ambulatory insulin infusion pump, electronic, software-dosing, scalar algorithm

A portable electronic device designed to provide continuous or intermittent subcutaneous delivery of insulin to a patient with diabetes mellitus, incorporating software to receive glucose status data from a monitor/transmitter and to determine the delivery of

US‑registered devices99in commercial distribution
Companies4labelers on GUDID
Single‑use4%of device records
Sterile2%labelled sterile
Prescription90%Rx‑only share
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Share of device records

Medtronic Minimed, Inc.5960%
Tandem Diabetes Care, Inc.3131%
Medtronic, Inc.88%
Sooil Development Co.,Ltd11%

Top labelers

CompanyDevicesShare
Medtronic Minimed, Inc.5960%
Tandem Diabetes Care, Inc.3131%
Medtronic, Inc.88%
Sooil Development Co.,Ltd11%

Company = labeler of record on GUDID. 4 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

MiniMed™ 780GMiniMed™ 770GMiniMed FlexMiniMed® 670GMiniMed®670GAdhesive Sleeve, 2 Pack, Tandem MobiAdhesive Sleeve, 10 Pack, Tandem MobiPharmacy Kit, Starter Pack, Tandem t:slim X2, CoTandem Mobi Mobile Application, iOSTandem Mobi Mobile Application, AndroidTandem Mobi Mobile ApplicationPharmacy Kit, Starter Pack, Tandem Mobi, ControlTandem Mobi, pump, Control-IQ 7.9t:slim Mobile Application, iOSTandem t:slim Mobile Application, AndroidTandem Mobi Starter Kit

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

FDA product codes

CodeNameDevices
OZPAutomated insulin dosing device system, single hormonal cont49
OYCPump, infusion, insulin, to be used with invasive glucose se47
QFGAlternate Controller Enabled Insulin Infusion Pump27
LZGPUMP, INFUSION, INSULIN11
OZOAutomated insulin dosing , threshold suspend9
NDCCalculator, drug dose8

GMDN & GCC registration

  • GMDN code 64891 · non‑implantable
  • Single‑use 4% · sterile 2% · Rx‑only 90% · 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, software-dosing, scalar algorithm products are registered in the US?

99 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, software-dosing, scalar algorithm", from 4 companies. The largest labeler is Medtronic Minimed, Inc. with 60% of records.

Which FDA product codes apply?

OZP (Automated insulin dosing device system, single hormonal cont), OYC (Pump, infusion, insulin, to be used with invasive glucose se), QFG (Alternate Controller Enabled Insulin Infusion Pump), 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.

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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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