Identity
- Trade Name
- VivaSight AS Pack Set include FDA UDI
- Generic Name
- Bronchial balloon catheter FDA UDI
- Device Name
- Oral/Nasal Cuffed visualization Endotracheal tube+Endobronchial blocker FDA UDI
- Model / Reference
- TVEB70100AS FDA UDI
- Description
- Oral/Nasal Cuffed visualization Endotracheal tube+Endobronchial blocker FDA UDI
Identifiers
- Catalog Number
- TVEB70100AS FDA UDI
- Primary DI / UDI-DI
- 07290013745774 FDA UDI
- FDA Product Code
- CBI FDA UDIBTR FDA UDI
- GMDN Term
- Bronchial balloon catheter FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5740 FDA UDI868.5730 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
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
MR Conditional FDA UDI
Category: Basic endotracheal tube, single-useBronchial balloon catheter
VivaSight AS Pack Set include by Etview , Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bronchial balloon catheter.
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- Elation™ — Merit Medical Systems, Inc. · Class II
- MultiStage® — Dongguan TT Medical, Inc. · Class II
- UNIBLOCKER — Fuji Systems Corp. · Class II
- INSPIRA AIR — ACCLARENT, INC. · Class II
- Blowfish Micro-Infusion Catheter — Mercator MedSystems, Inc. · Class II
Cleared under the same submission
K120334 also covers:
K152438 also covers:
- TRACHEOSCOPIC VENTILATION TUBE AS — Etview , Ltd.
- TRACHEOSCOPIC VENTILATION TUBE AS — Etview , Ltd.
- TRACHEOSCOPIC VENTILATION TUBE AS — Etview , Ltd.
- VivaSight AS Pack Set include — Etview , Ltd.
- VivaSight AS Pack Set include — Etview , Ltd.
- VivaSight Pack — Etview , Ltd.
- VivaSight Pack — Etview , Ltd.
- VivaSight Pack — Etview , Ltd.
- VivaSight-SL — Etview , Ltd.
- VivaSight-SL — Etview , Ltd.
- VivaSight-SL — Etview , Ltd.
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
- Etview , Ltd.
Sources (1)
- FDA UDI 0d9ede93-0538-492a-88af-cef7e2767426 36 fields · synced May 30, 2026