PRESTIGE AMERITECH, LTD.

Address:7201 Iron Horse Blvd.,North Richland Hills,TX,76180,US

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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) (9) Accessory, Surgical Apparel (LYU) (1)

Premarket Exempt

No Yes

Clear

ProGear - 00852212003207 Catalog Number :

Device Description : Imprints™ Customer Selected Custom Print Mask, Earloop (USA)

Device Class :

Duns Number: 199692794

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 50

ProKids - 00852212003214 Catalog Number :

Device Description : Imprints™ Pediatric Mask, Crayon Print, Earloop (USA)

Device Class :

Duns Number: 199692794

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 75

ProGear - 00852212003238 Catalog Number :

Device Description : Imprints™ Customer Selected Custom Print, Tie (USA)

Device Class :

Duns Number: 199692794

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 50

ProGear - 00852212003245 Catalog Number :

Device Description : Ported N95 Particulate Filter Respirator

Device Class :

Duns Number: 199692794

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 50

Prestige Ameritech - 00852212003252 Catalog Number :

Device Description : Fluid Resistant Earloop Mask, High Filtration

Device Class :

Duns Number: 199692794

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 50

ProKids - 00852212003269 Catalog Number :

Device Description : ProKids™ Child's Earloop Mask - Cook Children's Medical

Device Class :

Duns Number: 199692794

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 75

Prestige Ameritech - 00852212003276 Catalog Number :

Device Description : Fluid Resistant Surgical Tie Mask, High Filtration

Device Class :

Duns Number: 199692794

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 50

ProGear - 00852212003290 Catalog Number :

Device Description : PROGEAR® FULL FACE-SHIELD

Device Class :

Duns Number: 199692794

Premarket Exempt : Yes

Product Code : LYU

Prescription Use : No

Device Count : 24

ProGear - 00852212003313 Catalog Number :

Device Description : ProGear™ N95 Surgical Mask Respirator, Small, Fluid Resistant 160mm, White

Device Class :

Duns Number: 199692794

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 50

ProGear - 00852212003320 Catalog Number :

Device Description : ProGear™ N95 Surgical Mask Respirator, Regular, Fluid Resistant 160mm, Whit

Device Class :

Duns Number: 199692794

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 50

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