1. Vivit International Inc

1. Vivit International Inc

Address:2nd Floor, Balmoral Hall,Hastings Christ Church,BB

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Mask, Surgical (FXX) (10)

Premarket Exempt

No Yes

Clear

VIVIT - 10810084210014 Catalog Number :

Device Description : Medical Face Mask - Earloops, Yellow, 80mm Hg ASTM Level 1

Device Class :

Duns Number: 815240958

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 50

VIVIT - 10810084210038 Catalog Number :

Device Description : Medical Face Mask - Earloops, Blue, 80mm Hg ASTM Level 1

Device Class :

Duns Number: 815240958

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 50

VIVIT - 10810084210045 Catalog Number :

Device Description : Medical Face Mask - Earloops, Opal, 160mm Hg ASTM Level 3

Device Class :

Duns Number: 815240958

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 50

VIVIT - 10810084210052 Catalog Number :

Device Description : Medical Face Mask - Earloops, Anti-Fog Foam, Opal, 160mm Hg ASTM Level 3

Device Class :

Duns Number: 815240958

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 50

VIVIT - 10810084210069 Catalog Number :

Device Description : Medical Face Mask - Earloops, Anti-Fog Visor, Anti-Fog Foam, Opal, 160mm Hg ASTM Level 3

Device Class :

Duns Number: 815240958

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 25

VIVIT - 10810084210076 Catalog Number :

Device Description : Medical Face Mask - Ties, Blue, 80mm Hg ASTM Level 1

Device Class :

Duns Number: 815240958

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 50

VIVIT - 10810084210083 Catalog Number :

Device Description : Medical Face Mask - Ties, Soft, Dye Free, White, 80mm Hg ASTM Level 1

Device Class :

Duns Number: 815240958

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 50

VIVIT - 10810084210090 Catalog Number :

Device Description : Medical Face Mask - Ties, Soft, Dye Free, White, 160mm Hg ASTM Level 3

Device Class :

Duns Number: 815240958

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 50

VIVIT - 10810084210106 Catalog Number :

Device Description : Medical Face Mask - Ties, Duckbill, Green, 80mm Hg ASTM Level 1

Device Class :

Duns Number: 815240958

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 50

VIVIT - 10810084210113 Catalog Number :

Device Description : Medical Face Mask - Ties, Anti-Fog Foam, Blue, 80mm Hg ASTM Level 1

Device Class :

Duns Number: 815240958

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 50

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