GUDID 16938119388270

Oropharyngeal airway(Model:10.0#)

Henan Tuoren Medical Device Co.,Ltd.

Oropharyngeal airway, single-use
Primary Device ID16938119388270
NIH Device Record Key81a5120b-126e-47b3-996d-620bc9faaf3a
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberOropharyngeal airway(Model:10.0#)
Company DUNS526982680
Company NameHenan Tuoren Medical Device Co.,Ltd.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106938119388266 [Primary]
GS116938119388270 [Package]
Contains: 06938119388266
Package: Middle Box [50 Units]
In Commercial Distribution
GS126938119388284 [Package]
Package: Carton [4 Units]
In Commercial Distribution

FDA Product Code

CAEAirway, Oropharyngeal, Anesthesiology

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-11-28
Device Publish Date2022-11-19

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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