GUDID 06938119326497

The Endobronchial tube contians 1Pc Fr31 Left Endobronchial tube,1Pc Multifunctional joint and 2Pcs Fr8 Suction catheter, 1Pc Fr10 Suction catheter.

Henan Tuoren Medical Device Co.,Ltd.

Endobronchial tube
Primary Device ID06938119326497
NIH Device Record Keyddbb6c71-b90f-48bd-b172-6aebceb48acb
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberLeft:Fr31
Company DUNS526982680
Company NameHenan Tuoren Medical Device Co.,Ltd.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Catheter Gauge31 French

Device Identifiers

Device Issuing AgencyDevice ID
GS106938119326497 [Primary]
GS116938119326494 [Package]
Package: Case [10 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 Date2019-10-09
Device Publish Date2019-10-01

Devices Manufactured by Henan Tuoren Medical Device Co.,Ltd.

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16938119329525 - NA2022-11-28 Anesthetic Mask(Bending edge model:3#)
16938119329556 - NA2022-11-28 Anesthetic Mask(Bending edge model:4#)
16938119329587 - NA2022-11-28 Anesthetic Mask(Bending edge model:5#)
16938119329617 - NA2022-11-28 Anesthetic Mask( Detachable model:3#)
16938119329648 - NA2022-11-28 Anesthetic Mask( Detachable model:4#)

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