GUDID 16938119359874

Blockbuster Laryngeal Mask Airway(model:1.0# )

Henan Tuoren Medical Device Co.,Ltd.

Laryngeal mask airway, single-use
Primary Device ID16938119359874
NIH Device Record Key37a2041c-1bf4-421a-ab2e-2ed752895b04
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberBlockbuster Laryngeal Mask Airway(model:1.0# )
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
GS106938119359860 [Primary]
GS116938119359874 [Package]
Contains: 06938119359860
Package: Middle Box [5 Units]
In Commercial Distribution
GS126938119359888 [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#)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.