FDA.reportPublic FDA data

Resilient Medical Solutions

Primary DI
00850086117006
Brand
Resilient Medical Solutions
Company
Resilient Medical Solutions, LLC
Model
RMEM2
Device description
ASTM Level 2, Ear Loop Face Mask, Blue, 50/bx
Published
2026-05-20
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
FXXMask, Surgical

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850086117003PackageGS110In Commercial Distribution
00850086117006PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085008611700310850086117003
00850086117006008500861170068500861170060850086117006

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
076404432
Device count
1
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850061262936Resilient Medical SolutionsRMEG12502026-05-20
00850061262943Resilient Medical SolutionsRMEG22502026-05-20
00850061262950Resilient Medical SolutionsRMEG32502026-05-20
00850061262967Resilient Medical SolutionsRMEG42502026-05-20
00850061262974Resilient Medical SolutionsRMEG52302026-05-20
00850061262981Resilient Medical SolutionsRMEM1Y2026-05-20
00850061262998Resilient Medical SolutionsRMEM1F2026-05-20
00850086117013Resilient Medical SolutionsRMTM1AFB2026-05-20
00850086117020Resilient Medical SolutionsRMTM3AFB2026-05-20
00850037100507Resilient Medical SolutionsRMTD12023-08-16
00850037100514Resilient Medical SolutionsRMTD22023-08-16
00850037100521Resilient Medical SolutionsRMSH3L2023-07-31
00850037100538Resilient Medical SolutionsRMSH5L2023-07-31
00850037100545Resilient Medical SolutionsRMSH10L2023-07-31
00850037100552Resilient Medical SolutionsRMSH20L2023-07-31
00850037100569Resilient Medical SolutionsRMSH50L2023-07-31
00850061262899Resilient Medical SolutionsRMTMDBS32025-05-16
00850061262905Resilient Medical SolutionsRMSOTHYU2025-05-16
00850061262912Resilient Medical SolutionsRMAM1YU2025-05-16
00850061262929Resilient Medical SolutionsRMAM1YXL2025-05-16

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00681131106108EquateWAL-MART STORES, INC.FXX2026-02-25
00681131106092EquateWAL-MART STORES, INC.FXX2026-02-25
08809755250171KP Protective Face Mask KP trading Co., Ltd.FXX2026-02-19
10097604555514Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXX2025-07-28
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10371347011620Advance Dental ProductsThe Atlanta Dental Supply CompanyFXX2024-03-01
10097604543320Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXX2024-01-19
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10195327560522Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FXX2023-12-21
10097604537022Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXX2023-12-11
10097604538128Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXX2023-12-11
10304040169022EssentialsHENRY SCHEIN, INC.FXX2023-07-05
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10304040165253CriterionHENRY SCHEIN, INC.FXX2023-06-26
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10304040168490CriterionHENRY SCHEIN, INC.FXX2023-06-26
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10304040168612CriterionHENRY SCHEIN, INC.FXX2023-06-26
10304040168629CriterionHENRY SCHEIN, INC.FXX2023-06-26
10304040168643CriterionHENRY SCHEIN, INC.FXX2023-06-26
10304040168650CriterionHENRY SCHEIN, INC.FXX2023-06-26
10304040168926CriterionHENRY SCHEIN, INC.FXX2023-06-26