GUDID 16938119359911

Blockbuster Laryngeal Mask Airway(model:1.5# )

Henan Tuoren Medical Device Co.,Ltd.

Laryngeal mask airway, single-use Laryngeal mask airway, single-use Laryngeal mask airway, single-use Laryngeal mask airway, single-use Laryngeal mask airway, single-use Laryngeal mask airway, single-use Laryngeal mask airway, single-use Laryngeal mask airway, single-use Laryngeal mask airway, single-use Laryngeal mask airway, single-use Laryngeal mask airway, single-use
Primary Device ID16938119359911
NIH Device Record Key3c3be37c-0729-4212-9836-0b8f7fc1a3f9
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberBlockbuster Laryngeal Mask Airway(model:1.5# )
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
GS106938119359907 [Primary]
GS116938119359911 [Package]
Contains: 06938119359907
Package: Middle Box [5 Units]
In Commercial Distribution
GS126938119359925 [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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