UNIVENT TUBE (TCB TYPE) 1202933

GUDID 04544050056045

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

FUJI SYSTEMS CORPORATION

Endobronchial tube
Primary Device ID04544050056045
NIH Device Record Key6d25aaac-2c60-429c-a325-476e3dba83f9
Commercial Distribution StatusIn Commercial Distribution
Brand NameUNIVENT TUBE (TCB TYPE)
Version Model NumberI.D. 8.0MM
Catalog Number1202933
Company DUNS715919973
Company NameFUJI SYSTEMS CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numbertrue
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104544050056045 [Primary]

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 StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-09-24

On-Brand Devices [UNIVENT TUBE (TCB TYPE)]

04544050056076ENDOTRACHEAL TUBE, UNIVENT TUBE (TCB Type) is indicated for use in airway management of surgical
04544050056069ENDOTRACHEAL TUBE, UNIVENT TUBE (TCB Type) is indicated for use in airway management of surgical
04544050056052ENDOTRACHEAL TUBE, UNIVENT TUBE (TCB Type) is indicated for use in airway management of surgical
04544050056045ENDOTRACHEAL TUBE, UNIVENT TUBE (TCB Type) is indicated for use in airway management of surgical
04544050056038ENDOTRACHEAL TUBE, UNIVENT TUBE (TCB Type) is indicated for use in airway management of surgical
04544050056021ENDOTRACHEAL TUBE, UNIVENT TUBE (TCB Type) is indicated for use in airway management of surgical
04544050056014ENDOTRACHEAL TUBE, UNIVENT TUBE (TCB Type) is indicated for use in airway management of surgical
04544050056007ENDOTRACHEAL TUBE, UNIVENT TUBE (TCB Type) is indicated for use in airway management of surgical
04544050055987ENDOTRACHEAL TUBE, UNIVENT TUBE (TCB Type) is indicated for use in airway management of surgical
04544050055161ENDOTRACHEAL TUBE, UNIVENT TUBE (TCB Type) is indicated for use in airway management of surgical
04544050055154ENDOTRACHEAL TUBE, UNIVENT TUBE (TCB Type) is indicated for use in airway management of surgical
14544050123829ENDOTRACHEAL TUBE, UNIVENT TUBE (TCB Type) is indicated for use in airway management of surgical
14544050123805ENDOTRACHEAL TUBE, UNIVENT TUBE (TCB Type) is indicated for use in airway management of surgical
14544050123904ENDOTRACHEAL TUBE, UNIVENT TUBE (TCB Type) is indicated for use in airway management of surgical
14544050123898ENDOTRACHEAL TUBE, UNIVENT TUBE (TCB Type) is indicated for use in airway management of surgical
14544050123881ENDOTRACHEAL TUBE, UNIVENT TUBE (TCB Type) is indicated for use in airway management of surgical
14544050123874ENDOTRACHEAL TUBE, UNIVENT TUBE (TCB Type) is indicated for use in airway management of surgical
14544050123867ENDOTRACHEAL TUBE, UNIVENT TUBE (TCB Type) is indicated for use in airway management of surgical
14544050123850ENDOTRACHEAL TUBE, UNIVENT TUBE (TCB Type) is indicated for use in airway management of surgical
14544050123843ENDOTRACHEAL TUBE, UNIVENT TUBE (TCB Type) is indicated for use in airway management of surgical
14544050123836ENDOTRACHEAL TUBE, UNIVENT TUBE (TCB Type) is indicated for use in airway management of surgical
14544050123812ENDOTRACHEAL TUBE, UNIVENT TUBE (TCB Type) is indicated for use in airway management of surgical
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