Saf-T-Gard

Primary DI
G539MM3S2
Brand
Saf-T-Gard
Company
Saf-T-Gard International, Inc.
Model
MM-3S
Catalog number
MM-3S
Device description
Level 1 Face Mask, Blue
Published
2026-09-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
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
G539MM3S2PrimaryHIBCC0
G539MM3S0Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical/medical respirator, non-antimicrobial, single-useA form-shaped filtering mask designed to be placed over the nose and mouth of a healthcare worker to permit normal breathing while protecting the wearer and patient from large particles (e.g., body fluids, airborne particulate materials) and small particles (e.g., bacteria) during medical, surgical, dental, and isolation procedures; it does not include an antimicrobial agent(s). It is designed to create an airtight seal against the user’s face, and typically includes ties/head straps; it might incorporate a forming nosepiece (metal wire) and/or an exhalation valve. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
8472911600CustomerService@saftgard.com

Regulatory Flags#

DUNS number
025199415
Device count
2000
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G539MM3S1Saf-T-GardMM-3SMM-3S2026-09-21
G539MM3SB1Saf-T-GardMM-3SBMM-3SB2026-09-21
G539MM3SB2Saf-T-GardMM-3SBMM-3SB2026-09-21
G53986702XL1Ambi-Gard8670/2XL8670/2XL2023-10-12
G5398670L1Ambi-Gard8670/L8670/L2023-10-12
G5398670M1Ambi-Gard8670/M8670/M2023-10-12
G5398670S1Ambi-Gard8670/S8670/S2023-10-12
G5398670XL1Ambi-Gard8670/XL8670/XL2023-10-12
G53986702XL2Ambi-Gard8670/2XL8670/2XL2023-10-12
G5398670L2Ambi-Gard8670/L8670/L2023-10-12
G5398670M2Ambi-Gard8670/M8670/M2023-10-12
G5398670S2Ambi-Gard8670/S8670/S2023-10-12
G5398670XL2Ambi-Gard8670/XL8670/XL2023-10-12
G5398670XS1Ambi-Gard8670/XS86702023-10-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G539MM3S1Saf-T-GardSaf-T-Gard International, Inc.FXX2026-09-21
G539MM3SB1Saf-T-GardSaf-T-Gard International, Inc.FXX2026-09-21
G539MM3SB2Saf-T-GardSaf-T-Gard International, Inc.FXX2026-09-21
00050428143315CVSWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFXX2026-09-18
00050428340561CVSWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFXX2026-09-18
10304040195472EssentialsHENRY SCHEIN, INC.FXX2026-09-04
10304040195489EssentialsHENRY SCHEIN, INC.FXX2026-09-04
00810194402623AiraAIRA, LLCFXX2026-08-26
20197344219237MEDLINEMEDLINE INDUSTRIES, INC.FXX2026-07-31
06974960061330S&JXiantao S&J Protective Products Co., LtdFXX2026-07-29
00840456202814JMUJMU DENTAL, INCFXX2026-07-24
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