Device
MiiS Horus Bronchoscope (ECB 100S) is a single-use, flexible, sterile Bronchoscope. The device provides visualization for endoscopic procedures within the airways and tracheobronch...
Manufacturer
MEDIMAGING INTEGRATED SOLUTION INC.
MEDIMAGING INTEGRATED SOLUTION INC.
Model: 5005
DI: 04719872715108
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-04-29
Current Version: 2026-05-07
Description
MiiS Horus Bronchoscope (ECB 100S) is a single-use, flexible, sterile Bronchoscope. The device provides visualization for endoscopic procedures within the airways and tracheobronchial tree.
MiiS Horus Bronchoscope (ECB 100S) have an LED light source and a camera at the distal end of the applied part. The Bronchoscope needs to connect with its compatible display system MiiS Horus Endoscope Display System -Tablet (EDS 500) or MiiS Horus Endoscope Display System -Video Box (EVS 700) and the signal captured was then transmitted to the cable-connected display system. Both the Tablet and Video box are reusable devices.
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
d7b0b301-92f5-48d7-b422-b059689eaa03
Distribution Status:
In Commercial Distribution
DUNS Number:
656813438
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Item #1 - Pkg Type:
white box
Item #1 - Device ID:
14719872715105
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
5
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
04719872715108
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
04719872715108
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
GMDN
Code: 60963
Name: Flexible video bronchoscope, single-use
Definition:
An endoscope with a flexible inserted portion intended for endoscopic procedures of the airways and tracheobronchial tree (i.e., bronchoscopy). It typically consists of a handle portion and an insertion tube which includes working channels and a distal camera from which anatomical images are transmitted and displayed on a monitor (video bronchoscopy). It is typically intended for flexible optical intubation, airway inspection, and may be used to assist in other diagnostic or therapeutic procedures [e.g., bronchoalveolar lavage (BAL)]. This is a single-use device.
FDA Product Codes
EOQ
Bronchoscope (Flexible Or Rigid)