FDA.reportPublic FDA data

VivaSight AS Pack Set include

Primary DI
17290013745771
Brand
VivaSight AS Pack Set include
Company
E.T. VIEW LTD
Model
TVEB70100AS
Catalog number
TVEB70100AS
Device description
Oral/Nasal Cuffed visualization Endotracheal tube+Endobronchial blocker
Published
2018-02-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
false

Contact Domains#

Product Codes#

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

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K120334000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K120334000VIVA EBEtview , Ltd.2012-06-08CBI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17290013745771PackageGS15In Commercial Distribution
07290013745774PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1729001374577117290013745771
07290013745774072900137457747290013745774

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
+972722607060medical@ETView.com

Regulatory Flags#

DUNS number
534096359
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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
07290013745552VivaSight Pack TVEB75105TVEB751052016-09-24
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

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