Device
SU26EN70TSC055N Bivona DI: Non-Adjustable-Non-Wired-Non-Sterile
Manufacturer
ICU MEDICAL, INC.
ICU MEDICAL, INC.
Model: SU26EN70TSC055N
DI: 10887709193236
Status: New
MRI: MR Safe
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-14
Current Version: 2026-05-22
Description
SU26EN70TSC055N Bivona DI: Non-Adjustable-Non-Wired-Non-Sterile
Sterilization
Method Types - Sterilization Method:
Moist Heat or Steam Sterilization
Device Sterile:
No
Sterilization Prior To Use:
Yes
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
71552f0d-d823-4ea1-b1ce-cacf21bd2745
Distribution Status:
In Commercial Distribution
DUNS Number:
118380146
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
Device ID:
10887709193236
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 38792
Name: Tracheostomy tube, non-reinforced, non-customized, reusable
Definition:
A hollow cylinder designed to be inserted into an artificial opening made in the trachea (windpipe) during a tracheotomy to provide a patent airway; it is not custom-made for a specific patient and is not reinforced with a wire. It is typically constructed of metal [stainless steel, silver (Ag) and/or silver plated brass] or plastic and may include an inner cannula. It is available in cuffed, uncuffed, and/or fenestrated versions, and in a variety of shapes and sizes. It is secured in position by a tracheostomy tube holder fastened around the patient's neck. This is a reusable device.
FDA Product Codes
JOH
Tube tracheostomy and tube cuff
Premarket Submissions
Submission Number:
K923878
Supplement Number:
000