FDA.report

VIVIT Supply

Primary DI
20810141930005
Brand
VIVIT Supply
Company
Vivit Supply LLC
Model
10112EM
Device description
Medical Face Mask - Earloops, Yellow, 80mm Hg ASTM Level 1
Published
2023-09-15
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

Related Records

Product Codes

CodeName
FXXMask, Surgical

Product Code Classifications

CodeDeviceSpecialtyClass
FXXMask, SurgicalGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20810141930005PackageGS110In Commercial Distribution
10810141930008PrimaryGS10
00810141930001Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
2081014193000520810141930005
1081014193000810810141930008
00810141930001008101419300018101419300010810141930001

GMDN Terms

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

TypeLowHighCondition
Special Storage Condition, Specify00Store in cool, dry, and well ventilated space out of direct sunlight

Sterilization Methods

Method

Regulatory Flags

DUNS number
119042597
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
true
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 DIBrandModelCatalogPublished
20810141933792VIVIT Supply201012026-02-26
20810141933808VIVIT Supply201022026-02-26
20810141933815VIVIT Supply201032026-02-26
20810141933822VIVIT Supply201042026-02-26
20810141933839VIVIT Supply201052026-02-26
20810141933877VIVIT Supply708812026-02-25
00810141933880VIVIT Supply708822026-02-25
20810141933891VIVIT Supply708832026-02-25
20810141933907VIVIT Supply708842026-02-25
20810141933914VIVIT Supply708852026-02-25
20810141933747VIVIT Supply205512026-02-03
20810141933754VIVIT Supply205522026-02-03
20810141933761VIVIT Supply205532026-02-03
20810141933778VIVIT Supply205542026-02-03
20810141933785VIVIT Supply205552026-02-03
20810141933488VIVIT Supply1112LJ2025-09-18
20810141933495VIVIT Supply1113LJ2025-09-18
20810141933501VIVIT Supply1114LJ2025-09-18
20810141933518VIVIT Supply1115LJ2025-09-18
20810141933525VIVIT Supply1116LJ2025-09-18

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