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) (10)

Premarket Exempt

Yes

Clear

PRIMOBoot II - Bariatric - 00810006683585 Catalog Number : PBIIB

Device Description : PBIIB PRIMOBoot II - Bariatric 10/each

Device Class : 1

Duns Number: 958758146

Premarket Exempt : Yes

Product Code : FMP

Prescription Use : No

Device Count : 1

PRIMOBoot II w/wedge - Small - 00810006683592 Catalog Number : PBIISW

Device Description : PBIISW PRIMOBoot II w/wedge - Small 8/each

Device Class : 1

Duns Number: 958758146

Premarket Exempt : Yes

Product Code : FMP

Prescription Use : No

Device Count : 1

PRIMOBoot II w/wedge - Standard - 00810006683608 Catalog Number : PBIIW

Device Description : PBIIW PRIMOBoot II w/wedge - Standard 8/each

Device Class : 1

Duns Number: 958758146

Premarket Exempt : Yes

Product Code : FMP

Prescription Use : No

Device Count : 1

PRIMOBoot II w/wedge - Bariatric - 00810006683615 Catalog Number : PBIIBW

Device Description : PBIIBW PRIMOBoot II w/wedge - Bariatric 8/each

Device Class : 1

Duns Number: 958758146

Premarket Exempt : Yes

Product Code : FMP

Prescription Use : No

Device Count : 1

Preventive Pad - 00810006683622 Catalog Number : PPWD381645

Device Description : Preventive Pad - (38" x 16" x 4.5") - Wipe Down

Device Class : 1

Duns Number: 958758146

Premarket Exempt : Yes

Product Code : FMP

Prescription Use : No

Device Count : 1

Preventive Pad - 00810006683646 Catalog Number : PPWD381445

Device Description : Preventive Pad - (38" x 14" x 4.5") - Wipe Down

Device Class : 1

Duns Number: 958758146

Premarket Exempt : Yes

Product Code : FMP

Prescription Use : No

Device Count : 1

Wipe Down Body Wedge Set - 00810006683745 Catalog Number : BPW10F

Device Description : Wipe Down Body Wedge Set (1 each-BPW04F/ 1 each-BPW04FL) - 12/ST/CA

Device Class : 1

Duns Number: 958758146

Premarket Exempt : Yes

Product Code : FMP

Prescription Use : No

Device Count : 1

Wipe Down Body Wedge Set - 00810006683752 Catalog Number : BPW11F

Device Description : Wipe Down Body Wedge Set (2 each - BPW04F) 12 ST/CA

Device Class : 1

Duns Number: 958758146

Premarket Exempt : Yes

Product Code : FMP

Prescription Use : No

Device Count : 1

Wipe Down Body Wedge, Rounded - 00810006683769 Catalog Number : BPW04R

Device Description : Wipe Down Body Wedge w/Handle, Rounded - 15" Long

Device Class : 1

Duns Number: 958758146

Premarket Exempt : Yes

Product Code : FMP

Prescription Use : No

Device Count : 1

Wipe Down Body Wedge, Rounded - 00810006683776 Catalog Number : BPW04LR

Device Description : Wipe Down Body Wedge w/Handle, Rounded - 19" Long

Device Class : 1

Duns Number: 958758146

Premarket Exempt : Yes

Product Code : FMP

Prescription Use : No

Device Count : 1

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