FDA.reportPublic FDA data

LungVision Tool

Primary DI
07290017652023
Brand
LungVision Tool
Company
BODY VISION MEDICAL LTD
Model
Bridge
Catalog number
LV2055001
Device 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, 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.
Published
2018-07-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
EOQBronchoscope (Flexible Or Rigid)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EOQBronchoscope (Flexible Or Rigid)Ear, Nose, Throat2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K172955000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172955000LungVision ToolBodyvision Medical , Ltd.2018-04-26EOQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290017652023PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290017652023072900176520237290017652023

GMDN Terms#

Term, Definition table
TermDefinition
Bronchoscopic catheterA sterile, flexible, single lumen tube designed to be used as a conduit to the lung(s) for the delivery of another device (e.g., an emphysematous lung sealant) during a bronchoscopic procedure. It is typically made of synthetic materials that resist kinking (may be capable of bending 135 degrees or more without kinking) and is advanced through the working channel of a bronchoscope to the treatment site by the operator, typically a pulmonologist or thoracic surgeon. The distal tip may be marked with a band to facilitate visualization by the operator during the procedure. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
600280073
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290017652153LungVision ToolBridgeLV20550402021-10-20
07290017652160LungVision ToolBridgeLV20550412021-10-20
07290017652177LungVision ToolBridgeLV20550422021-10-20
07290017652184LungVision ToolBridgeLV20550432021-10-20
07290017652191LungVision SmartWireBridgeLV20550502021-10-13
07290017652139LungVision ToolBridgeLV20550302021-07-12
07290017652146LungVision ToolBridgeLV20550312021-07-12
07290017652108LungVision ToolBridgeLV20550112021-04-11
07290017652115LungVision ToolBridgeLV20550202021-07-12
07290017652122LungVision ToolBridgeLV20550212021-07-12
07290017652085LungVision SystemCoreLV10550022021-04-13
07290017652092LungVision ToolBridgeLV20550102021-04-13
07290017652061LungVision ToolBridgeLV20550042020-01-01
07290017652078LungVision ToolBridgeLV20550052020-01-01
07290017652047LungVision ToolBridgeLV20550032019-07-11
07290017652054LungVision ToolBridgeLV20550022019-07-11
07290017652030LungVision SystemCoreLV10550012019-05-29
07290017652016LungVision ToolBridgeLV20550002018-07-12

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