FDA.reportPublic FDA data

WYZ Face Mask

Primary DI
00860004437864
Brand
WYZ Face Mask
Company
Wyz Medical Supplies LLC
Model
2111
Device description
ASTM LEVEL 1 FACE MASK BLUE
Published
2021-01-18
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
00860004437871PackageGS140Not in Commercial Distribution
00860004437864PrimaryGS10
00860004437888Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860004437871008600044378718600044378710860004437871
00860004437864008600044378648600044378640860004437864
00860004437888008600044378888600044378880860004437888

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature0 Degrees Celsius40 Degrees Celsius
Handling Environment Temperature0 Degrees Fahrenheit104 Degrees Fahrenheit

Regulatory Flags#

DUNS number
117528113
Device count
50
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
00860004437833WYZ Face Mask21212021-01-09
00860004437871WYZ Face Mask21112021-01-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850064198751Aligned Medical SolutionsAligned Medical SolutionsLYU2026-09-23
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