SATCHEL

Basic Information

• Brand Name: SATCHEL
• Primary DI: 03770034761044
• Version / Model: SATCHEL
• 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: 66ab7b9a-1e7a-444c-8085-65d83877a9ef

Device Description

An electrically powered telemedicine case designed to enable real-time, interactive transmission of audio and visual data between two or more locations. The SATCHEL 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 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.

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	03770034761044	GS1