SILBRONCHO (LEFT LUNG) 1203539

GUDID 14544050123966

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.

FUJI SYSTEMS CORPORATION

Endobronchial tube
Primary Device ID14544050123966
NIH Device Record Keya4e2e5a5-92bf-40c4-8c57-81106335f122
Commercial Distribution StatusIn Commercial Distribution
Brand NameSILBRONCHO (LEFT LUNG)
Version Model Number#39
Catalog Number1203539
Company DUNS715919973
Company NameFUJI SYSTEMS CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104544050123969 [Primary]
GS114544050123966 [Package]
Contains: 04544050123969
Package: [1 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

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

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-09-13
Device Publish Date2023-09-05

On-Brand Devices [SILBRONCHO (LEFT LUNG)]

04544050061209SILBRONCHO Tube is intended for use in airway management of surgical patients to perform one-lun
04544050061193SILBRONCHO Tube is intended for use in airway management of surgical patients to perform one-lun
04544050061186SILBRONCHO Tube is intended for use in airway management of surgical patients to perform one-lun
04544050061148SILBRONCHO Tube is intended for use in airway management of surgical patients to perform one-lun
14544050123966SILBRONCHO Tube is intended for use in airway management of surgical patients to perform one-lun
14544050123959SILBRONCHO Tube is intended for use in airway management of surgical patients to perform one-lun
14544050123942SILBRONCHO Tube is intended for use in airway management of surgical patients to perform one-lun

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