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Bivona

FDA UDI

Class II (US FDA UDI)

by Icu Medical, Inc.

Identity

Trade Name
Bivona FDA UDI
Generic Name
Tracheostomy tube, reinforced, non-customized, reusable FDA UDI
Model / Reference
FT21BN35NGF066N FDA UDI

Identifiers

Primary DI / UDI-DI
15019517258097 FDA UDI
510(k) Number
K923878 FDA UDI
FDA Product Code
JOH FDA UDI
GMDN Term
Tracheostomy tube, reinforced, non-customized, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.5800 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI
MRI Safety
MR Conditional FDA UDI

Category: Tracheostomy tube, reinforced, non-customized, reusable

Bivona by Icu Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Tracheostomy tube, reinforced, non-customized, reusable.

Cleared under the same submission

K923878 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Icu Medical, Inc.

Sources (1)

  • FDA UDI 0beb78a9-f9a0-4efb-8803-26d96c8fb8b1 33 fields · synced Jun 8, 2026