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) (7) Patient Examination Glove, Specialty (LZC) (3) Polymer Patient Examination Glove (LZA) (3)

Premarket Exempt

No Yes

Clear

VIVIT - 10810084210120 Catalog Number :

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

Device Class :

Duns Number: 815240958

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 50

VIVIT - 10810084210137 Catalog Number :

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

Device Class :

Duns Number: 815240958

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 50

VIVIT - 10810084210144 Catalog Number :

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

Device Class :

Duns Number: 815240958

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 50

VIVIT - 10810084210151 Catalog Number :

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

Device Class :

Duns Number: 815240958

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 50

VIVIT - 10810084210168 Catalog Number :

Device Description : Medical Face Mask - Ties, 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 - 10810084210175 Catalog Number :

Device Description : Medical Face Mask - Ties, 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 - 10810084210182 Catalog Number :

Device Description : Medical Face Mask - Ties, Anti-Glare, Anti-Fog Visor, Anti-Fog Foam, Opal, 160mm Medical Face Mask - Ties, Anti-Glare, 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 - 10810084210199 Catalog Number :

Device Description : Nitrile Examination Glove, Powder-Free, Textured Fingertips, Chemotherapy Drug T Nitrile Examination Glove, Powder-Free, Textured Fingertips, Chemotherapy Drug Tested, Purple, X-Small

Device Class :

Duns Number: 815240958

Premarket Exempt : No

Product Code : LZA, LZC

Prescription Use : No

Device Count : 200

VIVIT - 10810084210205 Catalog Number :

Device Class :

Duns Number: 815240958

Premarket Exempt : No

Product Code : LZA, LZC

Prescription Use : No

Device Count : 200

VIVIT - 10810084210212 Catalog Number :

Device Class :

Duns Number: 815240958

Premarket Exempt : No

Product Code : LZA, LZC

Prescription Use : No

Device Count : 200

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