PRIMO INC

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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) (7) Device, Transfer, Patient, Manual (FMR) (3)

Premarket Exempt

Yes

Clear

Anti-Rotational Wedge for PRIMOBoot - 00810006680003 Catalog Number : ARW01

Device Description : Anti-Rotational Wedge for PRIMOBoot, Black

Device Class : 1

Duns Number: 958758146

Premarket Exempt : Yes

Product Code : FMP

Prescription Use : No

Device Count : 1

PRIMOBoot, Purple/Navy - Standard - 00810006680010 Catalog Number : BAB11000, BAB11000W

Device Description : BAB11000 PRIMOBoot, Purple/Navy - Standard 13/each;BAB11000W PRIMOBoot w/wedge, BAB11000 PRIMOBoot, Purple/Navy - Standard 13/each;BAB11000W PRIMOBoot w/wedge, Purple/Navy - Standard 8/each

Device Class :

Duns Number: 958758146

Premarket Exempt : Yes

Product Code : FMP

Prescription Use : No

Device Count : 1

PRIMOBoot, Bariatric (Navy/Gray) - 00810006680034 Catalog Number : BABB, BABBW

Device Description : BABB PRIMOBoot, Bariatric (Navy/Gray), 10/each;BABBW PRIMOBoot w/wedge, Bariatri BABB PRIMOBoot, Bariatric (Navy/Gray), 10/each;BABBW PRIMOBoot w/wedge, Bariatric (Navy/Gray), 8/each

Device Class :

Duns Number: 958758146

Premarket Exempt : Yes

Product Code : FMP

Prescription Use : No

Device Count : 1

Wipe Down Body Wedge w/Handle - Extra Long - 00810006680041 Catalog Number : BPW04XL

Device Description : Wipe Down Body Wedge w/Handle - Extra Long (24")

Device Class : 1

Duns Number: 958758146

Premarket Exempt : Yes

Product Code : FMP

Prescription Use : No

Device Count : 1

Wipe Down Body Wedge Set - Standard - 00810006680058 Catalog Number : BPW10

Device Description : Standard Wipe Down Body Wedge Set (1 each-Short / 1 each-Long)

Device Class : 1

Duns Number: 958758146

Premarket Exempt : Yes

Product Code : FMP

Prescription Use : No

Device Count : 1

Wipe Down Body Wedge Set - Standard - 00810006680065 Catalog Number : BPW11

Device Description : Standard Wipe Down Body Wedge Set (2 each - Short)

Device Class : 1

Duns Number: 958758146

Premarket Exempt : Yes

Product Code : FMP

Prescription Use : No

Device Count : 1

Glide & Guide Turn Sheet - 00810006680072 Catalog Number : GGS3660

Device Description : Glide & Guide Turn Sheet (36" x 60")

Device Class : 1

Duns Number: 958758146

Premarket Exempt : Yes

Product Code : FMR

Prescription Use : No

Device Count : 1

Glide & Guide Turn Sheet - 00810006680089 Catalog Number : GGS3660TS

Device Description : Glide & Guide Turn Sheet (36" x 60") w/Top Straps

Device Class : 1

Duns Number: 958758146

Premarket Exempt : Yes

Product Code : FMR

Prescription Use : No

Device Count : 1

Glide & Guide Turn Sheet - 00810006680096 Catalog Number : GGS5660

Device Description : Glide & Guide Turn Sheet - Bariatric (56" x 60")

Device Class : 1

Duns Number: 958758146

Premarket Exempt : Yes

Product Code : FMR

Prescription Use : No

Device Count : 1

Wipe Down Body Wedge Set - Bariatric - 00810006680102 Catalog Number : BPW20

Device Description : Bariatric Wipe Down Body Wedge Set (1 each-Short / 1 each-Long)

Device Class : 1

Duns Number: 958758146

Premarket Exempt : Yes

Product Code : FMP

Prescription Use : No

Device Count : 1

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