VivaSight-SL - Oral/Nasal Cuffed visualization Endotracheal tube - E.T. VIEW LTD

Duns Number:534096359

Device Description: Oral/Nasal Cuffed visualization Endotracheal tube

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More Product Details

Catalog Number

TVT75105

Brand Name

VivaSight-SL

Version/Model Number

TVT75105

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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

K152438,K152438,K152438

Product Code Details

Product Code

BTR

Product Code Name

Tube, Tracheal (W/Wo Connector)

Device Record Status

Public Device Record Key

1ba9769c-4767-4cad-8155-48bbc7318d0c

Public Version Date

June 19, 2020

Public Version Number

4

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

27290013745013

Quantity per Package

10

Contains DI Package

17290013745016

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton

"E.T. VIEW LTD" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 13