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Device Explorer · FDA GUDID · GMDN 64890

Ambulatory insulin infusion pump, electronic, software-dosing, binary 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 devices201in commercial distribution
Companies1labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription100%Rx‑only share
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Share of device records

Medtronic Minimed, Inc.201100%

Top labelers

CompanyDevicesShare
Medtronic Minimed, Inc.201100%

Company = labeler of record on GUDID. 1 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

MiniMed™ 630GMiniMed® 630GMiniMed® 670GMiniMed® 530GMiniMed®630GMedtronic MiniMed 530G

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

FDA product codes

CodeNameDevices
OZOArtificial pancreas device system, threshold suspend169
OZOAutomated insulin dosing , threshold suspend17
OZPAutomated insulin dosing device system, single hormonal cont14
OZPArtificial pancreas device system, single hormonal control1

GMDN & GCC registration

  • GMDN code 64890 · 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, software-dosing, binary algorithm products are registered in the US?

201 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, binary algorithm", from 1 companies. The largest labeler is Medtronic Minimed, Inc. with 100% of records.

Which FDA product codes apply?

OZO (Artificial pancreas device system, threshold suspend), OZO (Automated insulin dosing , threshold suspend), OZP (Automated insulin dosing device system, single hormonal cont), OZP (Artificial pancreas device system, single hormonal control)

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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