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Device Explorer · FDA GUDID · GMDN 58884

Self-care monitoring/reporting software

An application software program designed for the continual collection and aggregation of a patient's self-care data to promote communication between patient and healthcare provider, to facilitate a patient's self-care by using rules defined during use of the a

US‑registered devices235in commercial distribution
Companies26labelers on GUDID
Single‑use1%of device records
Sterile0%labelled sterile
Prescription68%Rx‑only share
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Share of device records

Respironics, Inc.14160%
Medtronic Minimed, Inc.188%
Apple Inc.104%
Roche Molecular Systems, Inc.83%
Naturalcycles Nordic Ab83%
Biowink Gmbh52%
Welldoc, Inc.52%
Qompium42%

Top labelers

CompanyDevicesShare
Respironics, Inc.14160%
Medtronic Minimed, Inc.188%
Apple Inc.104%
Roche Molecular Systems, Inc.83%
Naturalcycles Nordic Ab83%
Biowink Gmbh52%
Welldoc, Inc.52%
Qompium42%
Sugarmate, Llc42%
Abbott Diabetes Care Inc42%
Exer Labs, Inc.42%
Oncare Gmbh31%

Company = labeler of record on GUDID. 26 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Floodlight MS U-Turn TestFloodlight MS Draw Shape TestFloodlight MS Cognitive TestFloodlight MS Pinching TestPD Care SystemNatural CyclesNatural Cycles ApplicationFibriCheckClue AppClue ConceiveClue Birth ControlmyoncareVeris HealthCenter Health PHVANNE Link MobileClinical Data and Visualization Application

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

FDA product codes

CodeNameDevices
BZDVENTILATOR, NON-CONTINUOUS (RESPIRATOR)125
MNTVentilator, continuous, minimal ventilatory support, facilit99
MNSVENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING86
MNSVentilator, continuous, non-life-supporting40
MNTVENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY27
PHVContinuous Glucose Monitor Retrospective Data Analysis Softw19

GMDN & GCC registration

  • GMDN code 58884 · non‑implantable
  • Single‑use 1% · sterile 0% · Rx‑only 68% · OTC 15%
  • 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.

No closely related category with 50+ devices.

How many self-care monitoring/reporting software products are registered in the US?

235 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Self-care monitoring/reporting software", from 26 companies. The largest labeler is Respironics, Inc. with 60% of records.

Which FDA product codes apply?

BZD (VENTILATOR, NON-CONTINUOUS (RESPIRATOR)), MNT (Ventilator, continuous, minimal ventilatory support, facilit), MNS (VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING), MNS (Ventilator, continuous, non-life-supporting)

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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