GUDID 16938119326524

The Endobronchial tube contians 1Pc Fr37 Left Endobronchial tube,1Pc Multifunctional joint and 2Pcs Fr10 Suction catheter, 1Pc Fr16 Suction catheter.

Henan Tuoren Medical Device Co.,Ltd.

Endobronchial tube
Primary Device ID16938119326524
NIH Device Record Keyf4762c23-94e7-4618-be7a-a25bf2db4988
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberLeft:Fr37
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 Gauge37 French

Device Identifiers

Device Issuing AgencyDevice ID
GS106938119326527 [Primary]
GS116938119326524 [Package]
Contains: 06938119326527
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.

16938119329433 - NA2022-11-28
16938119329464 - NA2022-11-28
16938119329495 - NA2022-11-28 Anesthetic Mask(Bending edge model:2#)
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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