FDA.reportPublic FDA data

VivaSight-SL

Primary DI
07290013745002
Brand
VivaSight-SL
Company
E.T. VIEW LTD
Model
TVT70100
Catalog number
TVT70100
Device description
Oral/Nasal Cuffed visualization Endotracheal tube
Published
2016-09-24
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
BTRTube, Tracheal (W/Wo Connector)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTRTube, Tracheal (W/Wo Connector)Anesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K152438000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152438000ETView VivaSight-SL (TVT) systemEtview , Ltd.2016-02-25BTR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17290013745009PackageGS110In Commercial Distribution
27290013745006PackageGS110In Commercial Distribution
07290013745002PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1729001374500917290013745009
2729001374500627290013745006
07290013745002072900137450027290013745002

GMDN Terms#

Term, Definition table
TermDefinition
Basic endotracheal tube, single-useA hollow cylinder inserted orally or nasally into the trachea to provide an unobstructed airway to convey gases and vapours to and from the lungs during anaesthesia, resuscitation, and other situations where the patient is not properly ventilated. The device may: 1) be packaged with a connector that will attach to a breathing circuit or manual resuscitator; 2) have a distal inflatable cuff to seal against the tracheal wall; 3) be radiopaque; and 4) have a built-in pilot balloon for cuff pressure monitoring. It is typically made of plastic or rubber and is available in various diameters and lengths for adult and paediatric patients. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter7Millimeter

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

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

Regulatory Flags#

DUNS number
534096359
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
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
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
07290013745736VivaSight DL AS Set IncludesDLVT41LASDLVT41LAS2018-02-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00810003750563KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-01
00810003750570KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-01
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00810003750457KENTRONKENTRON HEALTHCARE, INC.BTR2026-05-27
00810003750464KENTRONKENTRON HEALTHCARE, INC.BTR2026-05-27
00810003750471KENTRONKENTRON HEALTHCARE, INC.BTR2026-05-27