Asp Global, LLC

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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

Protector, Skin Pressure (FMP) (3) Non-Surgical Isolation Gown (OEA) (2) Thermometer, Electronic, Clinical (FLL) (2) Cushion, Wheelchair (IMP) (1) Mask, Surgical (FXX) (1)

Premarket Exempt

No Yes

Clear

PRIMO - 00840216120648 Catalog Number :

Device Description : BUCK'S TRACTION W/FOOT POSITION & HEEL HOLE, PURPLE, 10EA/CS

Device Class : 1

Duns Number: 080361159

Premarket Exempt : Yes

Product Code : FMP

Prescription Use : No

Device Count : 1

PRIMO/ASP MEDICAL - 00840216120655 Catalog Number :

Device Description : SEAT CUSHION, 16"X18", 1/EA (COMPRESSED)

Device Class : 1

Duns Number: 080361159

Premarket Exempt : Yes

Product Code : IMP

Prescription Use : No

Device Count : 1

PRIMO - 00840216120662 Catalog Number :

Device Description : Encompass Health Foam Bed Positioning Wedge

Device Class : 1

Duns Number: 080361159

Premarket Exempt : Yes

Product Code : FMP

Prescription Use : No

Device Count : 1

ASP GLOBAL - 00840216120679 Catalog Number :

Device Description : GOWN, ISOLATION AAMI 2 PRINTED IN BLACK ON LEFT CHEST, UNIVERSAL, YELLOW, OVER T GOWN, ISOLATION AAMI 2 PRINTED IN BLACK ON LEFT CHEST, UNIVERSAL, YELLOW, OVER THE HEAD, FULL BACK, TIE WAIST, THUMBLOOP WITH ELASTIC WRIST, 10EA/BG, 10BG/CS (100EA/CS)

Device Class : 1

Duns Number: 080361159

Premarket Exempt : Yes

Product Code : OEA

Prescription Use : No

Device Count : 1

ASP GLOBAL - 00840216120686 Catalog Number :

Device Description : GOWN, ISOLATION AAMI 2 PRINTED IN BLACK ON LEFT CHEST, XLARGE, YELLOW, OVER THE GOWN, ISOLATION AAMI 2 PRINTED IN BLACK ON LEFT CHEST, XLARGE, YELLOW, OVER THE HEAD, FULL BACK, TIE WAIST, THUMBLOOP WITH ELASTIC WRIST, 10EA/BG, 10BG/CS (100EA/CS)

Device Class : 1

Duns Number: 080361159

Premarket Exempt : Yes

Product Code : OEA

Prescription Use : No

Device Count : 1

PRIMO - 00840216120778 Catalog Number :

Device Description : ECONOMY HEEL PROTECTIVE PAD W/COVER, 36"x12"x3", COMPRESSED 1 EA/BG, 12BG/CS

Device Class : 1

Duns Number: 080361159

Premarket Exempt : Yes

Product Code : FMP

Prescription Use : No

Device Count : 1

ASP GLOBAL - 10840216107608 Catalog Number :

Device Description : THERMOMETER, ORAL DIGITAL, ASP BLUE, 20 SECOND READ

Device Class :

Duns Number: 080361159

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 20

ASP GLOBAL - 10840216107622 Catalog Number :

Device Description : THERMOMETER, RECTAL DIGITAL, ASP RED, 20 SECOND READ

Device Class :

Duns Number: 080361159

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 20

ASP MEDICAL - 10840216107967 Catalog Number : FMT605

Device Description : MASK, SURGICAL, BLUE, EARLOOP 3-PLY, LEVEL 2, 50EA/BX, 40BX/CS (2000EA/CS)

Device Class :

Duns Number: 080361159

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 50

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