FDA.reportPublic FDA data

VivaSight Pack

Primary DI
07290013745552
Brand
VivaSight Pack
Company
E.T. VIEW LTD
Model
TVEB75105
Catalog number
TVEB75105
Device description
Oral/Nasal Cuffed visualization Endotracheal tube+Endobronchial blocker.
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BTRTube, Tracheal (W/Wo Connector)
CBITube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTRTube, Tracheal (W/Wo Connector)Anesthesiology2
CBITube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)Anesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K120334000
K152438000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K120334000VIVA EBEtview , Ltd.2012-06-08CBI
K152438000ETView VivaSight-SL (TVT) systemEtview , Ltd.2016-02-25BTR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17290013745559PackageGS15In Commercial Distribution
07290013745552PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1729001374555917290013745559
07290013745552072900137455527290013745552

GMDN Terms#

Term, Definition table
TermDefinition
Bronchial balloon catheterA sterile flexible tube designed with a balloon at or near the distal tip that may be introduced directly (usually under fluoroscopic guidance) or through a bronchoscope so that its distal tip reaches the bronchi, permitting the inflation of the balloon after introduction. The device is typically used to treat benign stenosis and strictures of the airway and/or to control pulmonary bleeding (i.e., hemoptysis). This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+972-722607060medical@ETView.com

Regulatory Flags#

DUNS number
534096359
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
07290013745293VivaSight-MaxSA00014SA000142016-09-25
07290013745019VivaSight-SLTVT75105TVT751052016-09-24
07290013745545VivaSight PackTVEB70100TVEB701002016-09-24
07290013745743TRACHEOSCOPIC VENTILATION TUBE ASTVT70100ASTVT70100AS2018-02-21
07290013745750TRACHEOSCOPIC VENTILATION TUBE ASTVT75105ASTVT75105AS2018-02-21
07290013745767TRACHEOSCOPIC VENTILATION TUBE ASTVT80110ASTVT80110AS2018-02-21
07290013745774VivaSight AS Pack Set includeTVEB70100ASTVEB70100AS2018-02-21
07290013745781VivaSight AS Pack Set includeTVEB75105ASTVEB75105AS2018-02-21
07290013745798VivaSight AS Pack Set includeTVEB80110ASTVEB80110AS2018-02-21
07290013745002VivaSight-SLTVT70100TVT701002016-09-24
07290013745026VivaSight-SLTVT80110TVT801102016-09-24
07290013745569VivaSight PackTVEB80110TVEB801102016-09-24
07290013745613VivaSight-DLDLVT39DLVT392016-09-24
07290013745514VivaSight-EBEBB09700EBB097002016-09-24
17290013745610VivaSight-DLDLVT39DLVT392016-09-24
07290013745620VivaSight-DLDLVT41DLVT412016-09-24
07290013745705VivaSight DL AS Set IncludesDLVT35LASDLVT35LAS2018-02-21
07290013745712VivaSight DL AS Set IncludesDLVT37LASDLVT37LAS2018-02-21
07290013745729VivaSight DL AS Set IncludesDLVT39LASDLVT39LAS2018-02-21
07290013745736VivaSight DL AS Set IncludesDLVT41LASDLVT41LAS2018-02-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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