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) (9) Aid, Transfer (IKX) (1)

Premarket Exempt

Yes

Clear

Guardian Heel Protector - 00810006680508 Catalog Number : HP201Y

Device Description : Guardian FALL RISK Heel Protector, Yellow

Device Class : 1

Duns Number: 958758146

Premarket Exempt : Yes

Product Code : FMP

Prescription Use : No

Device Count : 1

HeelShield - 00810006680515 Catalog Number : HS51, HS51W

Device Description : HS51 HeelShield - Standard 12/each;HS51W HeelShield w/wedge - Standard 8/each;

Device Class :

Duns Number: 958758146

Premarket Exempt : Yes

Product Code : FMP

Prescription Use : No

Device Count : 1

HeelShield - 00810006680522 Catalog Number : HS51B, HS51BW

Device Description : HS51B HeelShield - Bariatric 10/each;HS51BW HeelShield w/wedge - Bariatric 8/each

Device Class :

Duns Number: 958758146

Premarket Exempt : Yes

Product Code : FMP

Prescription Use : No

Device Count : 1

HeelShield - 00810006680539 Catalog Number : HS51S, HS51SW

Device Description : HS51S HeelShield - Small 12/each;HS51SW HeelShield w/wedge - Small 8/each

Device Class :

Duns Number: 958758146

Premarket Exempt : Yes

Product Code : FMP

Prescription Use : No

Device Count : 1

Knee Pillow - 00810006680546 Catalog Number : KP01

Device Description : Knee Pillow - Contoured Suede

Device Class : 1

Duns Number: 958758146

Premarket Exempt : Yes

Product Code : FMP

Prescription Use : No

Device Count : 1

Knee Pillow - 00810006680553 Catalog Number : KP03

Device Description : Knee Pillow - Contoured Wipe Down

Device Class : 1

Duns Number: 958758146

Premarket Exempt : Yes

Product Code : FMP

Prescription Use : No

Device Count : 1

Wheelchair Backpack - 00810006680560 Catalog Number : PM100

Device Description : Wheelchair Backpack

Device Class : 1

Duns Number: 958758146

Premarket Exempt : Yes

Product Code : IKX

Prescription Use : No

Device Count : 1

Preventive Pad - 00810006680577 Catalog Number : PP281645

Device Description : Preventive Pad - Standard (28" x 16" x 4.5")

Device Class : 1

Duns Number: 958758146

Premarket Exempt : Yes

Product Code : FMP

Prescription Use : No

Device Count : 1

Preventive Pad - 00810006680584 Catalog Number : PPSS281645

Device Description : Preventive Pad - Standard (28" x 16" x 4.5") - Sheepskin

Device Class : 1

Duns Number: 958758146

Premarket Exempt : Yes

Product Code : FMP

Prescription Use : No

Device Count : 1

Sheepskin Heel Protector - 00810006680997 Catalog Number : HPSS01

Device Description : Single Ply Sheepskin Economy Heel Protector

Device Class : 1

Duns Number: 958758146

Premarket Exempt : Yes

Product Code : FMP

Prescription Use : No

Device Count : 1

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