FDA.reportPublic FDA data

NA

Primary DI
06938119359259
Brand
NA
Company
Henan Tuoren Medical Device Co.,Ltd.
Model
Medical Laryngeal Mask Airway(Normal model:5.0# )
Device description
Medical Laryngeal Mask Airway(Normal model:5.0# )
Published
2022-11-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
CAEAirway, Oropharyngeal, Anesthesiology

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CAEAirway, Oropharyngeal, AnesthesiologyAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16938119359270PackageGS15In Commercial Distribution
26938119359284PackageGS110In Commercial Distribution
06938119359259PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1693811935927016938119359270
2693811935928426938119359284
06938119359259069381193592596938119359259

GMDN Terms#

Term, Definition table
TermDefinition
Laryngeal mask airway, single-useA curved tube with a distal inflatable cuff/mask intended to be used in inhalational anaesthesia and resuscitation to facilitate and secure airway patency for the delivery and exchange of gases in spontaneously breathing and ventilated patients. It is inserted into the hypopharynx above the glottis to create a seal and to prevent the tongue from obstructing the anatomical airway. It may include a 15 mm connector that attaches to a breathing circuit or manual resuscitator, be radiopaque, and have a built-in pilot balloon for cuff pressure monitoring. It is available in various sizes/designs and is typically made of silicone/plastic materials. This is a single-use device.

Regulatory Flags#

DUNS number
526982680
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06938119329429NABending edge:0#2022-11-18
06938119329450NABending edge:1#2022-11-18
06938119329481NABending edge:2#2022-11-18
06938119329511NABending edge:3#2022-11-18
06938119329542NABending edge:4#2022-11-18
06938119329573NABending edge:5#2022-11-18
06938119329603NA Detachable model:3#2022-11-18
06938119329634NA Detachable model:4#2022-11-18
06938119329665NA Detachable model:5#2022-11-18
06938119331071NAInfant2022-11-18
06938119331101NATracheotomy 2022-11-18
06938119359020NAMedical Laryngeal Mask Airway(Normal model:1.0# )2022-11-19
06938119359051NAMedical Laryngeal Mask Airway(Normal model:1.5# )2022-11-19
06938119359099NAMedical Laryngeal Mask Airway(Normal model:2.0# )2022-11-19
06938119359136NAMedical Laryngeal Mask Airway(Normal model:2.5# )2022-11-19
06938119359174NAMedical Laryngeal Mask Airway(Normal model:3.0# )2022-11-19
06938119359211NAMedical Laryngeal Mask Airway(Normal model:4.0# )2022-11-19
06938119359860NABlockbuster Laryngeal Mask Airway(model:1.0# )2022-11-19
06938119359907NABlockbuster Laryngeal Mask Airway(model:1.5# )2022-11-19
06938119359945NABlockbuster Laryngeal Mask Airway(model:2.0#)2022-11-19

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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