Duns Number:600280073
Device Description: The LungVision Tool is an instrument designed as a working channel intended to be used wit 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, LV2055001 is compatible with Olympus Bronchoscope BF-1TH190 LungVision Tool composed from: LungVision Handle, LungVision Adaptor for Olympus Bronchoscope BF-1TH190, LungVision Sheath and LungVision Wire.
Catalog Number
LV2055001
Brand Name
LungVision Tool
Version/Model Number
Bridge
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K172955
Product Code
EOQ
Product Code Name
Bronchoscope (Flexible Or Rigid)
Public Device Record Key
8b07c80d-293a-4c8e-9a66-33453b2d3f90
Public Version Date
May 27, 2022
Public Version Number
2
DI Record Publish Date
July 12, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 19 |