FDA.reportPublic FDA data

Britedent

Primary DI
D974BSIBL021
Brand
Britedent
Company
Bright Supply, Inc.
Model
BSI-BL02
Device description
3Ply Ear-Loop Mask Blue Level 2
Published
2023-09-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
OTC
true
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
D974BSIBL022PackageHIBCC40In Commercial Distribution
D974BSIBL021PrimaryHIBCC0
D974BSIBL020Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical/medical face mask, non-antimicrobial, single-useA flexible, loose-fitting mask designed to be placed over the mouth and/or nose of a healthcare worker to permit normal breathing while protecting the patient and wearer from the transfer of large particles (e.g., blood, body fluids, and airborne particulate materials). It does not include an antimicrobial/antiviral agent(s) and 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) and/or transparent face/eye visor. This is a single-use device.

Regulatory Flags#

DUNS number
124117012
Device count
50
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D974BSI20031BritedentBSI-20032024-06-07
D974BSI55001BritedentBSI-55002025-08-21
D974BSI55002BritedentBSI-55002025-08-21
D974BSI29111BritedentBSI-29112025-03-11
D974BSI29112BritedentBSI-29112025-03-11
D974BSI01021BritedentBSI-01022020-11-26
D974BSI01031BritedentBSI-01032021-07-31
D974BSI01051BritedentBSI-01052021-08-12
D974BSI25031BritedentBSI-25032023-07-28
D974BSI25041BritedentBSI-25042024-01-18
D974BSI25051BritedentBSI-25052022-03-18
D974BSI25071BritedentBSI-25072021-12-31
D974BSI29011BritedentBSI-29012021-03-30
D974BSI29031BritedentBSI-29032021-04-22
D974BSI29051BritedentBSI-29052021-04-22
D974BSI29061BritedentBSI-29062021-04-22
D974BSI29091BritedentBSI-29092021-03-30
D974BSI29101BritedentBSI-29102021-06-28
D974BSI29121BritedentBSI-29122021-04-22
D974BSI29131BritedentBSI-29132021-06-28

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
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
16975316480031BESTARWUHAN BESTAR INDUSTRY CO.,LTDKHA2022-12-19
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