FDA.reportPublic FDA data

EcoGuard® Surgical Mask

Primary DI
B927200292711
Brand
EcoGuard® Surgical Mask
Company
Ecoguard, Inc
Model
EcoGuard B
Catalog number
20029271
Device description
A 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.
Published
2024-06-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FXXMask, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FXXMask, SurgicalGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B927200292711PrimaryHIBCC0
B927200292710Unit 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.

Contacts#

Phone, Email table
PhoneEmail
+1(704)322-3709cs@ecoguard.us

Regulatory Flags#

DUNS number
117512312
Device count
50
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B927200206711EcoGuard® Surgical Mask EcoGuard B200206712024-06-05
B927200206831EcoGuard® Surgical Mask EcoGuard B200206832024-06-05
B927200289931EcoGuard® Surgical Mask EcoGuard B200289932024-06-05
B927200292191EcoGuard® Surgical Mask EcoGuard B200292192024-06-05
B927200292701EcoGuard® Surgical Mask EcoGuard B200292702024-06-05
B927200292721EcoGuard® Surgical Mask EcoGuard B200292722024-06-05
B927200292731EcoGuard® Surgical Mask EcoGuard B200292732024-06-05
B927200292741EcoGuard® Surgical Mask EcoGuard B200292742024-06-05
B927200292751EcoGuard® Surgical Mask EcoGuard B200292752024-06-05
B927200292761EcoGuard® Surgical Mask EcoGuard B200292762024-06-05
B927200292771EcoGuard® Surgical Mask EcoGuard B200292772024-06-05
B927200292781EcoGuard® Surgical Mask EcoGuard B200292782024-06-05
B927200292791EcoGuard® Surgical Mask EcoGuard B200292792024-06-05
B927200292801EcoGuard® Surgical Mask EcoGuard B200292802024-06-05
B927200206712EcoGuard® Surgical Mask EcoGuard B200206712024-06-05
B927200206830EcoGuard® Surgical Mask EcoGuard B200206832024-06-05
B927200289930EcoGuard® Surgical Mask EcoGuard B200289932024-06-05
B927200292192EcoGuard® Surgical Mask EcoGuard B200292192024-06-05
B927200292702EcoGuard® Surgical Mask EcoGuard B200292702024-06-05
B927200292710EcoGuard® Surgical Mask EcoGuard B200292712024-06-05

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10097604543320Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXX2024-01-19
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10097604573624Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXX2024-01-19
10195327560522Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FXX2023-12-21
10097604537022Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXX2023-12-11
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10304040168629CriterionHENRY SCHEIN, INC.FXX2023-06-26
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10304040168650CriterionHENRY SCHEIN, INC.FXX2023-06-26
10304040168926CriterionHENRY SCHEIN, INC.FXX2023-06-26
10304040168933CriterionHENRY SCHEIN, INC.FXX2023-06-26
10304040168940CriterionHENRY SCHEIN, INC.FXX2023-06-26
10087701434423Good NeighborShepard Medical Products, Inc.FXX2023-01-06
10096295122296LeaderShepard Medical Products, Inc.FXX2023-01-06
10096295137382LeaderShepard Medical Products, Inc.FXX2023-01-06