FDA.reportPublic FDA data

VIVIT

Primary DI
10810084210182
Brand
VIVIT
Company
1. Vivit International Inc
Model
313242TMV
Device description
Medical Face Mask - Ties, Anti-Glare, Anti-Fog Visor, Anti-Fog Foam, Opal, 160mm Hg ASTM Level 3
Published
2021-10-30
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
20810084210189PackageGS14Not in Commercial Distribution
10810084210182PrimaryGS10
00810084210185Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2081008421018920810084210189
1081008421018210810084210182
00810084210185008100842101858100842101850810084210185

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in cool, dry, and well ventilated space out of direct sunlight.

Regulatory Flags#

DUNS number
815240958
Device count
25
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
10810084210007VIVIT8440FW2022-10-28
10810084210014VIVIT10112EM2021-10-30
10810084210021VIVIT8441FW2022-10-28
10810084210038VIVIT10111EM2021-10-30
10810084210045VIVIT30114EM2021-10-30
10810084210052VIVIT31314EM2021-10-30
10810084210069VIVIT313141EMV2021-10-30
10810084210076VIVIT10311TM2021-10-30
10810084210083VIVIT10215TM2021-10-30
10810084210090VIVIT30215TM2021-10-30
10810084210106VIVIT10333TM2021-10-30
10810084210113VIVIT11311TM2021-10-30
10810084210120VIVIT13313TM2021-10-30
10810084210137VIVIT12313TM2021-10-30
10810084210144VIVIT11215TM2021-10-30
10810084210151VIVIT30314TM2021-10-30
10810084210168VIVIT31314TM2021-10-30
10810084210175VIVIT313241TMV2021-10-30
10810084210199VIVIT205212021-10-30
10810084210205VIVIT205222021-10-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850054870704BAYLAB USABaylab USA, LLCFXX2026-10-01
G539MM3S1Saf-T-GardSaf-T-Gard International, Inc.FXX2026-09-21
G539MM3S2Saf-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