FDA.reportPublic FDA data

SafeMask

Primary DI
00686864060888
Brand
SafeMask
Company
AMD Medicom Inc
Model
221514
Device description
Vision E/L white L3
Published
2024-11-12
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K222551000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K222551000Humask Pro Vision, Humask Pro Vision 3000Entreprise Premont, Inc.2022-11-10FXX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10686864060885PrimaryGS10
00686864060888Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1068686406088510686864060885
00686864060888006868640608886868640608880686864060888

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
+1 514-636-6262mkansou@medicom.ca

Regulatory Flags#

DUNS number
256880576
Device count
50
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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
10686864061950Ocean Pacific NeoNatural1228B-SP101228B-SP102026-07-13
10686864061967Ocean Pacific NeoNatural1228C-SP101228C-SP102026-07-13
10686864061974Ocean Pacific NeoNatural1228D-SP101228D-SP102026-07-13
10686864061868MEDICOM SAFESEAL76112761122026-06-25
10686864061875MEDICOM SAFESEAL76115761152026-06-25
10686864061899MEDICOM SAFESEAL76020760202026-06-25
10686864061905MEDICOM SAFESEAL76024760242026-06-25
10686864061912MEDICOM SAFESEAL76030760302026-06-25
10686864061929MEDICOM SAFESEAL76036760362026-06-25
10686864061936MEDICOM ASSUREMASK VALIANT205915-B205915-B2026-03-17
10686864061943MEDICOM ASSUREMASK VALIANT205915-C205915-C2026-03-17
20686864061933MEDICOM ASSUREMASK VALIANT205915-B205915-B2026-03-17
20686864061940MEDICOM ASSUREMASK VALIANT205915-C205915-C2026-03-17
10686864060946MEDICOM DENTICARE 10067100672026-02-25
10686864060953MEDICOM DENTICARE 10068100682026-02-25
20686864060943MEDICOM DENTICARE 10067100672026-02-25
20686864060950MEDICOM DENTICARE 10068100682026-02-25
D8304405061PROFESSIONAL'S CHOICE4405064405062026-02-10
D8305514331MEDICOM5514335514332026-02-10
D8304405062PROFESSIONAL'S CHOICE4405064405062026-02-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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