FDA.reportPublic FDA data

VIVIT

Primary DI
20810084210165
Brand
VIVIT
Company
1. Vivit International Inc
Model
31314TM
Device description
Medical Face Mask - Ties, Anti-Fog Foam, Opal, 160mm Hg ASTM Level 3
Published
2021-10-30
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

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
20810084210165PackageGS16In Commercial Distribution
10810084210168PrimaryGS10
00810084210161Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2081008421016520810084210165
1081008421016810810084210168
00810084210161008100842101618100842101610810084210161

GMDN Terms#

Term, Definition table
TermDefinition
Surgical/medical face mask, 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) during medical procedures and patient examination; 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 intended to protect the upper face/eyes from debris/fluid. 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
815240958
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
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
10810084210182VIVIT313242TMV2021-10-30
10810084210199VIVIT205212021-10-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20686864061933MEDICOM ASSUREMASK VALIANTAMD Medicom IncFXX2026-03-17
20686864061940MEDICOM ASSUREMASK VALIANTAMD Medicom IncFXX2026-03-17
00810194402715AiraAIRA, LLCFXX2026-03-10
00810194402746AiraAIRA, LLCFXX2026-03-10
00681131106092EquateWAL-MART STORES, INC.FXX2026-02-25
00068113110610EquateWAL-MART STORES, INC.FXX2026-02-25
10612479275932McKessonMCKESSON MEDICAL-SURGICAL INC.FXX2026-02-20
08809755250164KP Protective Face Mask KP trading Co., Ltd.FXX2026-02-19
00810132808135House Brand DentistryFrontier Dental Supply IncFXX2026-02-10
30197344179750MEDLINEMEDLINE INDUSTRIES, INC.FXX2026-01-29
10311917079629WalgreensWALGREEN CO.FXX2026-01-22
30197344153163MEDLINEMEDLINE INDUSTRIES, INC.FXX2026-01-21
00810194402678AiraAIRA, LLCFXX2026-01-16
00810194402692AiraAIRA, LLCFXX2026-01-16
00810194402708AiraAIRA, LLCFXX2026-01-16
00723896029886Practicon Bliss™ Level 3 Face Mask 50/Box BlackPRACTICON, INC.FXX2026-01-08
00723896029916Practicon Bliss™ Level 3 Face Mask 50/Box BluePRACTICON, INC.FXX2026-01-08
00850025515092BAYLAB USABaylab USA, LLCFXX2026-01-05
00810126504395Essentials by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCFXX2025-12-16
00810126504449Essentials by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCFXX2025-12-16
00810126504456Essentials by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCFXX2025-12-16
00810126504494Essentials by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCFXX2025-12-16
00810126504616Essentials by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCFXX2025-12-16
00810126504623Essentials by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCFXX2025-12-16
00810126505651Essentials by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCFXX2025-12-16
00810126505668Essentials by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCFXX2025-12-16
00817169029724The Essentials By 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCFXX2025-12-16
30197344149388MEDLINEMEDLINE INDUSTRIES, INC.FXX2025-12-05
10842942017466PRIMED / CaracalpriMED Medical Products IncFXX2025-11-20
10842942017473PRIMED / CaracalpriMED Medical Products IncFXX2025-11-20