UNIVENT TUBE (TCB TYPE) - ENDOTRACHEAL TUBE, UNIVENT TUBE (TCB Type) is - FUJI SYSTEMS CORPORATION

Duns Number:715919973

Device Description: ENDOTRACHEAL TUBE, UNIVENT TUBE (TCB Type) is indicated for use in airway management of su ENDOTRACHEAL TUBE, UNIVENT TUBE (TCB Type) is indicated for use in airway management of surgical patients to perform one-lung ventilation.

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More Product Details

Catalog Number

1202930

Brand Name

UNIVENT TUBE (TCB TYPE)

Version/Model Number

I.D. 7.0MM

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K894337

Product Code Details

Product Code

CBI

Product Code Name

Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)

Device Record Status

Public Device Record Key

1b549f6e-3f60-49e6-9fb3-721c2e3835d4

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 24, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"FUJI SYSTEMS CORPORATION" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 32