SILBRONCHO (LEFT LUNG) - SILBRONCHO Tube is intended for use in airway - FUJI SYSTEMS CORPORATION

Duns Number:715919973

Device Description: SILBRONCHO Tube is intended for use in airway management of surgical patients to perform o SILBRONCHO Tube is intended for use in airway management of surgical patients to perform one-lung ventilation in thoracic surgery, lung resection, VATS, lobectomy and etc.

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More Product Details

Catalog Number

1203537

Brand Name

SILBRONCHO (LEFT LUNG)

Version/Model Number

#37

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

K051522

Product Code Details

Product Code

CBI

Product Code Name

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

Device Record Status

Public Device Record Key

9cd83eb2-0b7d-42f8-b0ea-52bd708a54b1

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