FDA.reportPublic FDA data

Beesure

Primary DI
10817508023410
Brand
Beesure
Company
ASCEND EAGLE INCORPORATED
Model
BE2610
Device description
Beesure Radiant ASTM 3 Face Mask 40 /Bx , Lime
Published
2022-06-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LYUAccessory, Surgical Apparel

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LYUAccessory, Surgical ApparelGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20817508023417PackageGS18In Commercial Distribution
10817508023410PrimaryGS10
00817508023413Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2081750802341720817508023417
1081750802341010817508023410
00817508023413008175080234138175080234130817508023413

GMDN Terms#

Term, Definition table
TermDefinition
Surgical/medical respirator, non-antimicrobial, single-useA form-shaped filtering mask designed to be placed over the nose and mouth of a healthcare worker to permit normal breathing while protecting the wearer and patient from large particles (e.g., body fluids, airborne particulate materials) and small particles (e.g., bacteria) during medical, surgical, dental, and isolation procedures; it does not include an antimicrobial agent(s). It is designed to create an airtight seal against the user’s face, and typically includes ties/head straps; it might incorporate a forming nosepiece (metal wire) and/or an exhalation valve. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
7075536190jordan.lim@pro2s.com

Regulatory Flags#

DUNS number
167102750
Device count
40
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10817508022291CranberryCR39062025-09-02
10817508022321CranberryCR39072025-09-02
10817508023137CranberryCR39082025-09-02
10817508023861CranberryCR39092025-09-02
10817508022260CranberryCR39052025-09-02
20817508022298CranberryCR39062025-09-02
20817508022328CranberryCR39072025-09-02
20817508023134CranberryCR39082025-09-02
20817508023868CranberryCR39092025-09-02
10817508020082CranberryCR35752025-05-08
10817508020211CranberryCR35762025-05-08
10817508020327CranberryCR35772025-05-08
10817508020372CranberryCR35782025-05-08
10817508021713CranberryCR35792025-05-08
20817508020089CranberryCR35752025-05-08
20817508020218CranberryCR35762025-05-08
20817508020324CranberryCR35772025-05-08
20817508020379CranberryCR35782025-05-08
20817508021710CranberryCR35792025-05-08
10817508021249BeesureBE13222022-05-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00749756401753DeRoyalDEROYAL INDUSTRIES, INC.LYU2026-09-18
00749756401760DeRoyalDEROYAL INDUSTRIES, INC.LYU2026-09-18
00749756401777DeRoyalDEROYAL INDUSTRIES, INC.LYU2026-09-18
00749756401784DeRoyalDEROYAL INDUSTRIES, INC.LYU2026-09-18
00850078013101MAXAIRSyntech, Int'l Inc.LYU2026-08-26
00850078013118MAXAIRSyntech, Int'l Inc.LYU2026-08-26
00850078013125MAXAIRSyntech, Int'l Inc.LYU2026-08-26
00850078013132MAXAIRSyntech, Int'l Inc.LYU2026-08-26
00850078013149MAXAIRSyntech, Int'l Inc.LYU2026-08-26
00840456224571JMUJMU DENTAL, INCLYU2026-08-18
00840456224588JMUJMU DENTAL, INCLYU2026-08-18
00840456224595JMUJMU DENTAL, INCLYU2026-08-18
00840456224601JMUJMU DENTAL, INCLYU2026-08-18
00840456224618JMUJMU DENTAL, INCLYU2026-08-18
00840456218402JMUJMU DENTAL, INCLYU2026-07-06
00840456218419JMUJMU DENTAL, INCLYU2026-07-06
00840456218426JMUJMU DENTAL, INCLYU2026-07-06
00840456218433JMUJMU DENTAL, INCLYU2026-07-06
00840456218440JMUJMU DENTAL, INCLYU2026-07-06
00840456218457JMUJMU DENTAL, INCLYU2026-07-06
00840456218464JMUJMU DENTAL, INCLYU2026-07-06
00840456218471JMUJMU DENTAL, INCLYU2026-07-06
00840456218488JMUJMU DENTAL, INCLYU2026-07-06
00840456218495JMUJMU DENTAL, INCLYU2026-07-06
00840456220894JMUJMU DENTAL, INCLYU2026-07-06
00840456220900JMUJMU DENTAL, INCLYU2026-07-06
00840456220917JMUJMU DENTAL, INCLYU2026-07-06
00840456220924JMUJMU DENTAL, INCLYU2026-07-06
00840456220931JMUJMU DENTAL, INCLYU2026-07-06
00840456220948JMUJMU DENTAL, INCLYU2026-07-06