Identity
- Trade Name
- Bivona FDA UDI
- Generic Name
- Tracheostomy tube, non-reinforced, non-customized, single-use FDA UDI
- Model / Reference
- AT14AS70NSC572N FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10351688701381 FDA UDI
- 510(k) Number
- K923878 FDA UDI
- FDA Product Code
- JOH FDA UDI
- GMDN Term
- Tracheostomy tube, non-reinforced, non-customized, single-use 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
Yes
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
Moist Heat or Steam Sterilization FDA UDI
MR Conditional FDA UDI
Category: Tracheostomy tube, non-reinforced, non-customized, single-use
Bivona by Icu Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Tracheostomy tube, non-reinforced, non-customized, single-use.
- Shiley — Covidien LP · Class II
- TRACOE mini — Tracoe medical GmbH · Class II
- PRIMEDISILK® Silikonkanüle, Gr.10 Länge 62 mm ohne Konnektor — Primed Halberstadt Medizintechnik GmbH · Class IIb
- Tracheal Stent with Mesh and Posts — HOOD, E BENSON LABORATORIES INC · Class II
- Trachealkanüle PRIMEDISTOM®, Gr.10, L = 85 mm — Primed Halberstadt Medizintechnik GmbH · Class IIb
- Shiley — Covidien LP · Class II
- Trachealkanüle Ultrasoft Suction Gr.8 — Primed Halberstadt Medizintechnik GmbH · Class IIb
- Silber Innenkanüle mit Adaptionsring für rundes Kastenventil gesiebt — Theodor Labarre Werkstätte für silb. chirurg. Instrumente GmbH · Class IIb
Cleared under the same submission
K923878 also covers:
- Bivona — ICU MEDICAL, INC.
- Bivona — ICU MEDICAL, INC.
- Bivona — ICU MEDICAL, INC.
- Bivona — ICU MEDICAL, INC.
- Bivona — ICU MEDICAL, INC.
- Bivona — ICU MEDICAL, INC.
- Bivona — ICU MEDICAL, INC.
- Bivona — ICU MEDICAL, INC.
- Bivona — ICU MEDICAL, INC.
- Bivona — ICU MEDICAL, INC.
- Bivona — ICU MEDICAL, INC.
- Bivona — ICU MEDICAL, INC.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Icu Medical, Inc.
Sources (1)
- FDA UDI 037621aa-7e42-4538-b344-40da3456e74c 33 fields · synced May 30, 2026