Identity
- Trade Name
- Bivona FDA UDI
- Generic Name
- Tracheostoma button FDA UDI
- Model / Reference
- BV0918 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 35021312009808 FDA UDI
- 510(k) Number
- K810436 FDA UDI
- FDA Product Code
- BTO FDA UDI
- GMDN Term
- Tracheostoma button 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 Safe FDA UDI
Category: Tracheostoma button
Bivona by Icu Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Tracheostoma button.
- Montgomery® Short-Term Cannula — Boston Medical Products, Inc. · Class II
- Provox Life LaryButton 12/18 — ATOS MEDICAL INC. · Class I
- Montgomery® Initial Cannula Set — Boston Medical Products, Inc. · Class II
- Provox LaryButton 14/8 — ATOS MEDICAL INC. · Class I
- Provox Life LaryButton 18/18 — ATOS MEDICAL INC. · Class I
- Montgomery® Initial Cannula Set — Boston Medical Products, Inc. · Class II
- Montgomery® Long-Term Cannula — Boston Medical Products, Inc. · Class II
- Montgomery® Long-Term Cannula — Boston Medical Products, Inc. · Class II
Cleared under the same submission
K810436 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Icu Medical, Inc.
Sources (1)
- FDA UDI 76af82a8-17c7-4dca-8218-9ed225651444 33 fields · synced May 30, 2026