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

HeelCheck - 00810006680119 Catalog Number : HC1

Device Description : HeelCheck - Standard

Device Class : 1

Duns Number: 958758146

Premarket Exempt : Yes

Product Code : FMP

Prescription Use : No

Device Count : 1

HeelCheck - 00810006680126 Catalog Number : HC1W

Device Description : HeelCheck - Standard (w/wedge)

Device Class : 1

Duns Number: 958758146

Premarket Exempt : Yes

Product Code : FMP

Prescription Use : No

Device Count : 1

HeelCheck - 00810006680133 Catalog Number : HCBW

Device Description : HeelCheck - Bariatric (w/wedge)

Device Class : 1

Duns Number: 958758146

Premarket Exempt : Yes

Product Code : FMP

Prescription Use : No

Device Count : 1

HeelCheck - 00810006680140 Catalog Number : HCS

Device Description : HeelCheck - Small

Device Class : 1

Duns Number: 958758146

Premarket Exempt : Yes

Product Code : FMP

Prescription Use : No

Device Count : 1

Guardian Mid-Calf Heel Protector - 00810006680157 Catalog Number : HP211P

Device Description : Guardian Mid-Calf Heel Protector (Purple/Navy)

Device Class : 1

Duns Number: 958758146

Premarket Exempt : Yes

Product Code : FMP

Prescription Use : No

Device Count : 1

Air Float Static Air Seat Cushion - 00810006680164 Catalog Number : AF171715

Device Description : Air Float Static Air Seat Cushion (17"x17"x1.5")

Device Class : 1

Duns Number: 958758146

Premarket Exempt : Yes

Product Code : FMP

Prescription Use : No

Device Count : 1

Air Float Static Air Seat Cushion - 00810006680171 Catalog Number : AF1919

Device Description : AirFloat Static Air Seat Cushion (19"x19")

Device Class :

Duns Number: 958758146

Premarket Exempt : Yes

Product Code : FMP

Prescription Use : No

Device Count : 1

Air Float Static Air Seat Cushion - 00810006680188 Catalog Number : AF2822

Device Description : AirFloat Static Air Seat Cushion Bariatric (28"x22")

Device Class :

Duns Number: 958758146

Premarket Exempt : Yes

Product Code : FMP

Prescription Use : No

Device Count : 1

Air Float Static Air Mattress Overlay - 00810006680195 Catalog Number : AF76343

Device Description : Air Float Static Air Mattress Overlay ( 76"x34"x3")

Device Class : 1

Duns Number: 958758146

Premarket Exempt : Yes

Product Code : FMP

Prescription Use : No

Device Count : 1

Air Float Static Air Mattress Overlay - 00810006680201 Catalog Number : AF76473

Device Description : Air Float Static Air Mattress Overlay Bariatric (76"x47"'x3")

Device Class : 1

Duns Number: 958758146

Premarket Exempt : Yes

Product Code : FMP

Prescription Use : No

Device Count : 1

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