FDA.reportPublic FDA data

Plant Based Procedural Mask

Primary DI
00850037747382
Brand
Plant Based Procedural Mask
Company
Safesource Direct, L.L.C.
Model
PM3003-W-ECO
Device description
Plant Based Procedural Mask ASTM Level 3 with ear loops
Published
2024-04-05
Public version status
Update
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
10850037747389PackageGS124In Commercial Distribution
00850037747382PrimaryGS10
00850060904080Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085003774738910850037747389
00850037747382008500377473828500377473820850037747382
00850060904080008500609040808500609040800850060904080

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
3372107920general@safesourcedirect.com

Regulatory Flags#

DUNS number
118070602
Device count
50
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850037747467Extra Large Blue Shoe CoverSC30022024-10-10
00850037747474Universal Shoe Cover Super TreadSC30032024-10-10
00850037747481Extra Large Extra Traction Shoe CoverSC30042024-10-10
10850037747464Extra Large Blue Shoe CoverSC30022024-10-10
10850037747471Universal Shoe Cover Super TreadSC30032024-10-10
10850037747488Extra Large Extra Traction Shoe CoverSC30042024-10-10
00850037747221"Bouffant Cap 21"" White"BHC30021WE2024-10-01
00850037747238"Bouffant Cap 21"" Blue"BHC30021BE2024-10-01
00850037747245"Bouffant Cap 24"" White"BHC30024WE2024-10-01
00850037747252"Bouffant Cap 24"" Blue"BHC30024BE2024-10-01
10850037747228Bouffant Cap 21" WhiteBHC30021WE2024-10-01
10850037747235Bouffant Cap 21" BlueBHC30021BE2024-10-01
10850037747242Bouffant Cap 24" WhiteBHC30024WE2024-10-01
10850037747259Bouffant Cap 24" BlueBHC30024BE2024-10-01
00850037747122SafeSource Direct Level 1 Surgical Mask with TiesSM30012023-05-16
00850037747139SafeSource Direct Level 3 Surgical Mask with TiesSM30032023-05-16
00850037747146SafeSource Direct Level 1 Procedure Mask with Ear LoopsPM30012023-05-16
00850037747269SafeSource Shoe CoversSC30012023-05-16
00850037747153SafeSource Direct Level 3 Procedure Mask with Ear LoopsPM30032023-05-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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16980077680095AOKAOK TOOLING LIMITEDFXX2026-05-28
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10097604573624Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXX2024-01-19
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