FDA.reportPublic FDA data

NA

Primary DI
06938119329481
Brand
NA
Company
Henan Tuoren Medical Device Co.,Ltd.
Model
Bending edge:2#
Device description
Anesthetic Mask(Bending edge model:2#)
Published
2022-11-18
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
BSJMask, Gas, Anesthetic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BSJMask, Gas, AnestheticAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16938119329495PackageGS125In Commercial Distribution
26938119329508PackageGS12In Commercial Distribution
06938119329481PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1693811932949516938119329495
2693811932950826938119329508
06938119329481069381193294816938119329481

GMDN Terms#

Term, Definition table
TermDefinition
Anaesthesia face mask, single-useA flexible, form-shaped device designed to be placed over a patient's nose and/or mouth to direct anaesthetic gases to the upper airway. It is made of conductive or non-conductive rubber, polyvinyl chloride (PVC), or other sterilizable materials that produce a soft, flexible cover to create an airtight seal against the patient's face. It typically includes a 22 mm connector (adult) or a 15 mm connector (paediatric), and is available in a range of sizes. It may be stabilized with a headstrap. This device is sometimes used in association with a manual resuscitator. 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
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
06938119359907NABlockbuster Laryngeal Mask Airway(model:1.5# )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
10192253071405CARDINAL HEALTHCardinal Health 200, LLCBSJ2026-04-06
10192253071412CARDINAL HEALTHCardinal Health 200, LLCBSJ2026-03-23
10192253071429CARDINAL HEALTHCardinal Health 200, LLCBSJ2026-03-23
10192253071436CARDINAL HEALTHCardinal Health 200, LLCBSJ2026-03-23
10192253071443CARDINAL HEALTHCardinal Health 200, LLCBSJ2026-03-23
10192253071450CARDINAL HEALTHCardinal Health 200, LLCBSJ2026-03-23
10192253071467CARDINAL HEALTHCardinal Health 200, LLCBSJ2026-03-23
10197344137435MEDLINEMEDLINE INDUSTRIES, INC.BSJ2025-03-05
10197344131662MEDLINEMEDLINE INDUSTRIES, INC.BSJ2025-01-31
10197344131693MEDLINEMEDLINE INDUSTRIES, INC.BSJ2025-01-31
10197344131723MEDLINEMEDLINE INDUSTRIES, INC.BSJ2025-01-31
10612479274218McKessonMCKESSON MEDICAL-SURGICAL INC.BSJ2025-01-31
10612479274232McKessonMCKESSON MEDICAL-SURGICAL INC.BSJ2025-01-31
10612479274256McKessonMCKESSON MEDICAL-SURGICAL INC.BSJ2025-01-31
10612479274270McKessonMCKESSON MEDICAL-SURGICAL INC.BSJ2025-01-31
10612479274294McKessonMCKESSON MEDICAL-SURGICAL INC.BSJ2025-01-31
10197344131679MEDLINEMEDLINE INDUSTRIES, INC.BSJ2025-01-23
10197344131686MEDLINEMEDLINE INDUSTRIES, INC.BSJ2025-01-23
10197344131709MEDLINEMEDLINE INDUSTRIES, INC.BSJ2025-01-23
10197344131716MEDLINEMEDLINE INDUSTRIES, INC.BSJ2025-01-23
10197344103706MEDLINEMEDLINE INDUSTRIES, INC.BSJ2024-06-10
10193489135367MedlineMEDLINE INDUSTRIES, INC.BSJ2024-04-24
10193489135374MedlineMEDLINE INDUSTRIES, INC.BSJ2024-04-24
10193489135381MedlineMEDLINE INDUSTRIES, INC.BSJ2024-04-24
10197344097180MedlineMEDLINE INDUSTRIES, INC.BSJ2024-04-23
10197344097197MedlineMEDLINE INDUSTRIES, INC.BSJ2024-04-23
10197344097203MedlineMEDLINE INDUSTRIES, INC.BSJ2024-04-23
10197344097210MedlineMEDLINE INDUSTRIES, INC.BSJ2024-04-23
10197344097227MedlineMEDLINE INDUSTRIES, INC.BSJ2024-04-23
10197344097234MedlineMEDLINE INDUSTRIES, INC.BSJ2024-04-23