FDA.reportPublic FDA data

NA

Primary DI
06974599110010
Brand
NA
Company
Changsha Magill Medical Technology Co., Ltd.
Model
MGL-VLMA-A1-#3
Published
2021-10-29
Public version status
Update
Distribution status
Not 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
16974599110017PackageGS130Not in Commercial Distribution
06974599110010PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697459911001716974599110017
06974599110010069745991100106974599110010

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
703075567
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06974599110515NAMGL-FT-62023-01-13
06974599110522NAMGL-FT-C2023-01-13
06974599110539NAA82024-03-22
06974599110546NAB82024-03-22
06974599110447NAMGL-SP-C2022-08-23
06974599110003NAMGL-SP-62021-10-29
06974599110027NAMGL-VLMA-A1-#42021-10-29
06974599110034NAMGL-VLMA-A1-#52021-10-29
06974599110454NAELB-12023-01-13
06974599110461NASTR-12023-01-13
06974599110478NATRI-22023-01-13
06974599110485NAEJT-12023-01-13
06974599110492NATRI-12023-01-13
06974599110508NAEXT-12023-01-13
86974599110450NAELB-12023-01-13
86974599110467NASTR-12023-01-13
86974599110474NATRI-22023-01-13
86974599110481NAEJT-12023-01-13
86974599110498NATRI-12023-01-13
86974599110504NAEXT-12023-01-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06946430427632CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDCAE2026-08-08
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