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

Device, Transfer, Patient, Manual (FMR) (5) Protector, Skin Pressure (FMP) (5)

Premarket Exempt

Yes

Clear

Anti-Rotational Wedge for HeelShield - 00810006680218 Catalog Number : ARW03

Device Description : Anti-Rotational Wedge for HeelShield, Green

Device Class : 1

Duns Number: 958758146

Premarket Exempt : Yes

Product Code : FMP

Prescription Use : No

Device Count : 1

PRIMOBoot, Purple/Gray - Small - 00810006680225 Catalog Number : BABS

Device Description : PRIMOBoot, Purple/Gray - Small

Device Class : 1

Duns Number: 958758146

Premarket Exempt : Yes

Product Code : FMP

Prescription Use : No

Device Count : 1

Wipe Down Body Wedge w/Handle - Standard - 00810006680232 Catalog Number : BPW04

Device Description : Wipe Down Body Wedge w/Handle - Standard (15” x 9” x 11”)

Device Class : 1

Duns Number: 958758146

Premarket Exempt : Yes

Product Code : FMP

Prescription Use : No

Device Count : 1

Wipe Down Body Wedge w/Handle - Long - 00810006680249 Catalog Number : BPW04L

Device Description : Wipe Down Body Wedge w/Handle - Long (19” x 9” x 11”)

Device Class : 1

Duns Number: 958758146

Premarket Exempt : Yes

Product Code : FMP

Prescription Use : No

Device Count : 1

Wipe Down Cushion - 00810006680256 Catalog Number : DUPC1618

Device Description : Wipe Down Cushion (16" x 18" x 4.5")

Device Class :

Duns Number: 958758146

Premarket Exempt : Yes

Product Code : FMP

Prescription Use : No

Device Count : 1

Glide & Guide Turn Sheet Select - 00810006680355 Catalog Number : GGS3660F

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 Select - 00810006680362 Catalog Number : GGS3660SSF

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

Device Class : 1

Duns Number: 958758146

Premarket Exempt : Yes

Product Code : FMR

Prescription Use : No

Device Count : 1

Glide & Guide Turn Sheet - 00810006680379 Catalog Number : GGS3660SS

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

Device Class : 1

Duns Number: 958758146

Premarket Exempt : Yes

Product Code : FMR

Prescription Use : No

Device Count : 1

Glide & Guide Turn Sheet Select - 00810006680386 Catalog Number : GGS3660TSF

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 - 00810006680393 Catalog Number : GGS4460

Device Description : Glide & Guide Turn Sheet (44" x 60")

Device Class : 1

Duns Number: 958758146

Premarket Exempt : Yes

Product Code : FMR

Prescription Use : No

Device Count : 1

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