Identity
- Trade Name
- LungVision Tool FDA UDI
- Generic Name
- Bronchoscopic catheter FDA UDI
- Device Name
- The LungVision Tool is an instrument designed as a working channel intended to be used with standard bronchoscopes, endo-therapy accessories and ultrasound probe to guide the endo-therapy accessories or ultrasound probe to the target area, specifically within the respiratory system. LungVision Tool, LV2055000 is compatible with Olympus Bronchoscope BF-1T160 / BF-1T180 LungVision Tool composed from: LungVision Handle, LungVision Adaptor for Olympus Bronchoscope BF-1T180, LungVision Sheath and LungVision Wire. FDA UDI
- Model / Reference
- Bridge FDA UDI
- Description
- The LungVision Tool is an instrument designed as a working channel intended to be used with standard bronchoscopes, endo-therapy accessories and ultrasound probe to guide the endo-therapy accessories or ultrasound probe to the target area, specifically within the respiratory system. LungVision Tool, LV2055000 is compatible with Olympus Bronchoscope BF-1T160 / BF-1T180 LungVision Tool composed from: LungVision Handle, LungVision Adaptor for Olympus Bronchoscope BF-1T180, LungVision Sheath and LungVision Wire. FDA UDI
Identifiers
- Catalog Number
- LV2055000 FDA UDI
- Primary DI / UDI-DI
- 07290017652016 FDA UDI
- 510(k) Number
- K172955 FDA UDI
- FDA Product Code
- EOQ FDA UDI
- GMDN Term
- Bronchoscopic catheter FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.4680 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
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
Category: Bronchoscopic catheter
LungVision Tool by Bodyvision Medical , Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Bronchoscopic catheter.
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- BroncTru™ Transbronchial Access Tool — BRONCUS MEDICAL INC. · Class II
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Cleared under the same submission
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
- Bodyvision Medical , Ltd.
Sources (1)
- FDA UDI 7f4a544f-8856-48f0-85fa-b2b44e8050e5 35 fields · synced Jun 8, 2026