HOPACK

Basic Information

• Brand Name: HOPACK
• Primary DI: 03770034761037
• Version / Model: HOPACK
• Company Name: HOPI MEDICAL
• Labeler DUNS: 277415043
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-01-28
• Public Version: 1
• Public Version Date: 2026-02-05
• Public Version Status: New
• Public Device Record Key: 1e178d01-955a-4525-b352-36a8705c401b

Device Description

An electrically powered telemedicine back-pack designed to enable real-time, interactive transmission of audio and visual data between two or more locations. The HOPACK teleconsultation back-pack 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 backpack. 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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OUG	Medical Device Data System	General Hospital	880.6310	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63383	Video consultation telemedicine system	A electrically-powered device designed for use in telemedicine to provide real-time and interactive transmission of images and sound between two or more sites, enabling a healthcare professional to communicate with other professionals or directly with a patient. It consists of VDU, camera, speaker, and headphone components that may be integrated (or attached to) a mobile or hand-held unit which has rechargeable batteries, or as components that can be connected to a television; there may be optional accessories to provide additional functionality (e.g., stethoscope). It can be used within or between healthcare facilities, or a professional facility and the home.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	03770034761037	GS1