FDA.reportPublic FDA data

BESTAR

Primary DI
16975316480031
Brand
BESTAR
Company
WUHAN BESTAR INDUSTRY CO.,LTD
Model
BSH2155
Published
2022-12-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
KHAMask, Scavenging

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KHAMask, ScavengingAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16975316480031PrimaryGS10
06975316480034Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697531648003116975316480031
06975316480034069753164800346975316480034

GMDN Terms#

Term, Definition table
TermDefinition
Public face mask, single-useA flexible, loose-fitting mask designed to be placed over the mouth and/or nose of a member of the general public to permit normal breathing while protecting the wearer from the transfer of large particles (e.g., blood, body fluids, and airborne particulate materials) from the environment; it is not a form-shaped filtering device (i.e., not a respirator). It is made of a flexible, porous fabric or paper material and is typically secured using elastic head straps or ties; it may incorporate a forming nosepiece (metal wire). This is a single-use device.

Regulatory Flags#

DUNS number
415986449
Device count
50
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00816711024972MATRX SCAV(WO/HOOD)WO/SHUTOFFPARKER-HANNIFIN CORPORATIONKHA2026-02-23
00810339030315SAFE DENTBGSS Company Inc.KHA2024-05-15
00810339031121SAFE DENTBGSS Company Inc.KHA2024-05-15
00810339030322SAFE DENTBGSS Company Inc.KHA2024-05-15
00810339031138SAFE DENTBGSS Company Inc.KHA2024-05-15
00813830027464Axess CapnographyAdaptersACCUTRON, INC.KHA2023-09-22
D974BSIBL011BritedentBright Supply, Inc.KHA2023-09-18
D974BSIBL021BritedentBright Supply, Inc.KHA2023-09-18
D974BSIBL012BritedentBright Supply, Inc.KHA2023-09-18
D974BSIBL022BritedentBright Supply, Inc.KHA2023-09-18
D1243I50NE0SolidexCreo Dent Hudson Valley, Inc.KHA2023-06-07
D1243I50TC0SolidexCreo Dent Hudson Valley, Inc.KHA2023-06-07
04260635790431AirTechniquesBaldus Sedation GmbH & Co. KGKHA2023-01-05
04260635790523AirTechniquesBaldus Sedation GmbH & Co. KGKHA2023-01-05
04260635790547AirTechniquesBaldus Sedation GmbH & Co. KGKHA2023-01-05
04260635790448AirTechniquesBaldus Sedation GmbH & Co. KGKHA2023-01-05
04260635790479AirTechniquesBaldus Sedation GmbH & Co. KGKHA2023-01-05
04260635790486AirTechniquesBaldus Sedation GmbH & Co. KGKHA2023-01-05
04260635790530AirTechniquesBaldus Sedation GmbH & Co. KGKHA2023-01-05
04260635790554AirTechiquesBaldus Sedation GmbH & Co. KGKHA2023-01-05
04260635790578AirTechniquesBaldus Sedation GmbH & Co. KGKHA2023-01-05
04260635790585AirTechniquesBaldus Sedation GmbH & Co. KGKHA2023-01-05
04260635790592AirTechniquesBaldus Sedation GmbH & Co. KGKHA2023-01-05
04260635790608AirTechniquesBaldus Sedation GmbH & Co. KGKHA2023-01-05
06933192201112Hakuna MatataFUJIAN BBC INCKHA2022-12-07
00816711020769Matrx Scavenger Large Nasal InhalerPARKER-HANNIFIN CORPORATIONKHA2022-12-06
04260635790103AirTechniquesBaldus Sedation GmbH & Co. KGKHA2022-12-02
04260635790158AirTechniquesBaldus Sedation GmbH & Co. KGKHA2022-12-02
04260635790493AirTechniquesBaldus Sedation GmbH & Co. KGKHA2022-12-02
04260635790714AirTechniquesBaldus Sedation GmbH & Co. KGKHA2022-12-02