FDA.reportPublic FDA data

NA

Primary DI
06938119359907
Brand
NA
Company
Henan Tuoren Medical Device Co.,Ltd.
Model
Blockbuster Laryngeal Mask Airway(model:1.5# )
Device description
Blockbuster Laryngeal Mask Airway(model:1.5# )
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
16938119359911PackageGS15In Commercial Distribution
26938119359925PackageGS14In Commercial Distribution
06938119359907PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1693811935991116938119359911
2693811935992526938119359925
06938119359907069381193599076938119359907

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
06938119359259NAMedical Laryngeal Mask Airway(Normal model:5.0# )2022-11-19
06938119359860NABlockbuster Laryngeal Mask Airway(model:1.0# )2022-11-19
06938119359945NABlockbuster Laryngeal Mask Airway(model:2.0#)2022-11-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05060112310058LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2026-08-03
05060112310065LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2026-08-03
05060112310607LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2026-08-03
15060112314183LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2026-08-01
05060112310041LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2026-07-31
05060112310621LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2026-07-31
05060112310638LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2026-07-31
05060112310645LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2026-07-31
05060112310652LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2026-07-31
05060112310683LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2026-07-31
15060112316200LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2026-07-30
05060112310072LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2026-07-29
05060112310089LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2026-07-29
05060112310096LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2026-07-29
05060112310102LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2026-07-29
05060112310119LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2026-07-29
05060112310157LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2026-07-29
05060112310164LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2026-07-29
05060112310171LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2026-07-29
05060112310188LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2026-07-29
05060112310195LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2026-07-29
05060112310201LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2026-07-29
05060112310676LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2026-07-29
10888277699472MEDLINEMEDLINE INDUSTRIES, INC.CAE2026-07-29
10888277699489MEDLINEMEDLINE INDUSTRIES, INC.CAE2026-07-29
10888277699496MEDLINEMEDLINE INDUSTRIES, INC.CAE2026-07-29
10888277699502MEDLINEMEDLINE INDUSTRIES, INC.CAE2026-07-29
10888277699533MEDLINEMEDLINE INDUSTRIES, INC.CAE2026-07-29
15060112314176LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2026-07-29
15060112316132LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2026-07-29