Device
FT26DN30NGA206N Bivona DI: Non-Adjustable-Wired_Non-Sterile
Manufacturer
ICU MEDICAL, INC.
ICU MEDICAL, INC.
Model: FT26DN30NGA206N
DI: 10887709191812
Status: New
MRI: MR Conditional
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-04-27
Current Version: 2026-05-05
Description
FT26DN30NGA206N Bivona DI: Non-Adjustable-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:
b5c93a3c-41bb-43e2-8a0c-2fb19b5b7cda
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:
10887709191812
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 63798
Name: Tracheostomy tube, reinforced, non-customized, reusable
Definition:
An armoured, hollow cylinder that is inserted into an artificial opening made in the trachea (windpipe) during a tracheotomy to provide a patent airway, typically for a patient with unusual neck mass, however it is not custom-made for a specific patient. It is constructed of plastic with wire reinforcement to provide additional resistance to kinking and may include an inner cannula. It is available in cuffed, uncuffed versions, and in a variety of sizes. It is typically secured in position by a tracheostomy tube holder fastened around the patient's neck. This is a single-patient, reusable device after appropriate cleaning.
FDA Product Codes
JOH
Tube tracheostomy and tube cuff
Premarket Submissions
Submission Number:
K923878
Supplement Number:
000