FDA.reportPublic FDA data

Richmond Dental & Medical

Primary DI
10695190405833
Brand
Richmond Dental & Medical
Company
BARNHARDT MANUFACTURING COMPANY
Model
400583
Catalog number
400583
Device description
Path-O-Guard, Level III Earloop Face Mask Anti-fluid/Anti-fog pink
Published
2016-08-15
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
FXXMask, Surgical

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10695190405833PrimaryGS10
00695190405836Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1069519040583310695190405833
00695190405836006951904058366951904058360695190405836

GMDN Terms#

Term, Definition table
TermDefinition
Surgical/medical face mask, 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) during medical procedures and patient examination; 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 intended to protect the upper face/eyes from debris/fluid. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
855-841-0743rdcustsvc@barnhardt.net

Regulatory Flags#

DUNS number
003148285
Device count
50
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10695190405017Richmond Dental & Medical4005014005012016-08-09
10695190405024Richmond Dental & Medical4005024005022016-08-15
10695190405031Richmond Dental & Medical4005034005032016-08-15
10695190405048Richmond Dental & Medical4005044005042016-08-15
10695190405055Richmond Dental & Medical4005054005052016-08-15
10695190405062Richmond Dental & Medical4005064005062016-08-15
10695190405093Richmond Dental & Medical4005094005092016-08-15
10695190405109Richmond Dental & Medical4005104005102016-08-15
10695190405116Richmond Dental & Medical4005114005112016-08-15
10695190405819Richmond Dental & Medical4005814005812016-08-15
10695190405826Richmond Dental & Medical4005824005822016-08-15
10695190405840Richmond Dental & Medical4005844005842016-08-15
10695190405895Richmond Dental & Medical4005894005892016-08-15
10695190405901Richmond Dental & Medical4005904005902016-08-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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16980077680149AOKAOK TOOLING LIMITEDFXX2026-06-04
16980077680156AOKAOK TOOLING LIMITEDFXX2026-06-04
16980077680163AOKAOK TOOLING LIMITEDFXX2026-06-04
16980077680101AOKAOK TOOLING LIMITEDFXX2026-06-03
16980077680118AOKAOK TOOLING LIMITEDFXX2026-06-03
16980077680125AOKAOK TOOLING LIMITEDFXX2026-06-03
16980077680132AOKAOK TOOLING LIMITEDFXX2026-06-03
16980077680071AOKAOK TOOLING LIMITEDFXX2026-05-28
16980077680088AOKAOK TOOLING LIMITEDFXX2026-05-28
16980077680095AOKAOK TOOLING LIMITEDFXX2026-05-28
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00681131106092EquateWAL-MART STORES, INC.FXX2026-02-25
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10097604555514Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXX2025-07-28
10371347011606Advance Dental ProductsThe Atlanta Dental Supply CompanyFXX2024-03-01
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10097604543320Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXX2024-01-19
10097604553022Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXX2024-01-19
10097604563229Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXX2024-01-19
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
10097604538128Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXX2023-12-11
10304040169022EssentialsHENRY SCHEIN, INC.FXX2023-07-05
10304040169039EssentialsHENRY SCHEIN, INC.FXX2023-07-05