FDA.reportPublic FDA data

SafeSource Direct Level 3 Surgical Mask with Ties

Primary DI
00850037747139
Brand
SafeSource Direct Level 3 Surgical Mask with Ties
Company
Safesource Direct, L.L.C.
Model
SM3003
Device description
Blue ASTM Level 3 Surgical Mask with Ties
Published
2023-05-16
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K221134000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K221134000Procedure Mask with Ear Loops and Surgical Mask with TiesSafesource Direct, LLC2022-05-19FXX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850037747136PackageGS112In Commercial Distribution
00850037747139PrimaryGS10
00850037747610Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085003774713610850037747136
00850037747139008500377471398500377471390850037747139
00850037747610008500377476108500377476100850037747610

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
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
00850037747382Plant Based Procedural MaskPM3003-W-ECO2024-04-05
00850037747122SafeSource Direct Level 1 Surgical Mask with TiesSM30012023-05-16
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
Primary DIBrandCompanyProduct codePublished
00840456202807JMUJMU DENTAL, INCFXX2026-07-23
00840456214664JMUJMU DENTAL, INCFXX2026-07-23
00840456214671JMUJMU DENTAL, INCFXX2026-07-23
00840456214688JMUJMU DENTAL, INCFXX2026-07-23
00840456214695JMUJMU DENTAL, INCFXX2026-07-23
30197344201697MEDLINEMEDLINE INDUSTRIES, INC.FXX2026-07-20
00810145950975NeuMask PinkMedgluv Inc.FXX2026-07-17
00850005229728NeuMask OrangeMedgluv Inc.FXX2026-07-17
00850086117037Resilient Medical SolutionsResilient Medical Solutions, LLCFXX2026-07-08
00840456202722JMUJMU DENTAL, INCFXX2026-07-07
00840456202739JMUJMU DENTAL, INCFXX2026-07-07
00840456202746JMUJMU DENTAL, INCFXX2026-07-07
00840456214619JMUJMU DENTAL, INCFXX2026-07-07
00840456214626JMUJMU DENTAL, INCFXX2026-07-07
00840456214633JMUJMU DENTAL, INCFXX2026-07-07
00840456214640JMUJMU DENTAL, INCFXX2026-07-07
00840456214657JMUJMU DENTAL, INCFXX2026-07-07
00810145952696NeuMask BlackMedgluv Inc.FXX2026-06-30
00850056441261Target Up&UpTARGET CORPORATIONFXX2026-06-25
00850056441254Target Up&UpTARGET CORPORATIONFXX2026-06-25
16980077680262AOKAOK TOOLING LIMITEDFXX2026-06-24
16980077680255AOKAOK TOOLING LIMITEDFXX2026-06-22
00842942008894PRIMEDpriMED Medical Products IncFXX2026-06-21
06922820992584GraidRfx+Care Manufacturing Co., Ltd.FXX2026-06-09
16980077680217AOKAOK TOOLING LIMITEDFXX2026-06-08
16980077680224AOKAOK TOOLING LIMITEDFXX2026-06-08
16980077680231AOKAOK TOOLING LIMITEDFXX2026-06-08
16980077680248AOKAOK TOOLING LIMITEDFXX2026-06-08
16980077680170AOKAOK TOOLING LIMITEDFXX2026-06-05
16980077680187AOKAOK TOOLING LIMITEDFXX2026-06-05