FMC

GUDID 03770034761020

An electrically powered telemedicine case designed to enable real-time, interactive transmission of audio and visual data between two or more locations. The FMC teleconsultation case allows healthcare professionals to communicate remotely with other professionals or directly with patients. The system includes a built-in screen, camera, microphone, and speaker, mounted in a hard, mobile case. It is designed to accommodate and interconnect medical devices and optional accessories (such as a digital stethoscope, otoscope, ECG, or other examination devices) to facilitate remote clinical assessments.

HOPI MEDICAL

Video consultation telemedicine system
Primary Device ID03770034761020
NIH Device Record Key67b1b509-e90d-4d0b-939b-21fc20b45401
Commercial Distribution StatusIn Commercial Distribution
Brand NameFMC
Version Model NumberFMC
Company DUNS277415043
Company NameHOPI MEDICAL
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS103770034761020 [Primary]

FDA Product Code

OUGMedical Device Data System

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-02-05
Device Publish Date2026-01-28

Devices Manufactured by HOPI MEDICAL

03770034761006 - LIMSTAR2026-02-05 An electrically powered telemedicine cart designed to enable real-time, interactive transmission of audio and visual data betwee
03770034761013 - MINILIM2026-02-05 An electrically powered telemedicine cart designed to enable real-time, interactive transmission of audio and visual data betwee
03770034761020 - FMC2026-02-05An electrically powered telemedicine case designed to enable real-time, interactive transmission of audio and visual data between two or more locations. The FMC teleconsultation case allows healthcare professionals to communicate remotely with other professionals or directly with patients. The system includes a built-in screen, camera, microphone, and speaker, mounted in a hard, mobile case. It is designed to accommodate and interconnect medical devices and optional accessories (such as a digital stethoscope, otoscope, ECG, or other examination devices) to facilitate remote clinical assessments.
03770034761020 - FMC2026-02-05 An electrically powered telemedicine case designed to enable real-time, interactive transmission of audio and visual data betwee
03770034761037 - HOPACK2026-02-05 An electrically powered telemedicine back-pack designed to enable real-time, interactive transmission of audio and visual data b
03770034761044 - SATCHEL2026-02-05 An electrically powered telemedicine case designed to enable real-time, interactive transmission of audio and visual data betwee
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