ARROWHEAD HEALTHCARE SUPPLY, LLC

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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

Mattress, Air Flotation, Alternating Pressure (FNM) (9) Thermometer, Electronic, Clinical (FLL) (1)

Premarket Exempt

Yes

Clear

ArroAir DigiMax 8 LPM pump - 00852685007009 Catalog Number :

Device Description : ArroAir DigiMax 8 LPM pump

Device Class : 2

Duns Number: 078585060

Premarket Exempt : Yes

Product Code : FNM

Prescription Use : No

Device Count : 1

ArroAir Deluxe LAL/AP Mattress w/ DigiMax Pump - 00852685007016 Catalog Number :

Device Description : ArroAir Deluxe LAL/AP Mattress w/ DigiMax Pump

Device Class : 2

Duns Number: 078585060

Premarket Exempt : Yes

Product Code : FNM

Prescription Use : No

Device Count : 1

ArroAir Max Pump Only - 00852685007023 Catalog Number :

Device Description : ArroAir Max Pump Only

Device Class : 2

Duns Number: 078585060

Premarket Exempt : Yes

Product Code : FNM

Prescription Use : No

Device Count : 1

ArroAir Premier LAL/AP Mattress w/ DigiMax Pump - 00852685007030 Catalog Number :

Device Description : ArroAir Premier LAL/AP Mattress w/ DigiMax Pump

Device Class : 2

Duns Number: 078585060

Premarket Exempt : Yes

Product Code : FNM

Prescription Use : No

Device Count : 1

ArroAir Elite - 00869937000022 Catalog Number :

Device Description : ArroAir Elite Alternating Pressure Mattress Overlay system

Device Class : 2

Duns Number: 078585060

Premarket Exempt : Yes

Product Code : FNM

Prescription Use : No

Device Count : 1

ArroTemp Infrared Thermometer - 00869937000039 Catalog Number :

Device Description : ArroTemp Infrared non-contact Thermometer

Device Class : 2

Duns Number: 078585060

Premarket Exempt : Yes

Product Code : FLL

Prescription Use : No

Device Count : 1

ArroAir Max & Essential - 00869937000046 Catalog Number :

Device Description : ArroAir Max & Essential LAL/AP Mattress System, 8” Air Cells Only

Device Class : 2

Duns Number: 078585060

Premarket Exempt : Yes

Product Code : FNM

Prescription Use : No

Device Count : 1

ArroAir Max & Deluxe - 00869937000053 Catalog Number :

Device Description : ArroAir Max & Deluxe LAL/AP Mattress System, 5” Air Cells with 3" Foam Cells sec ArroAir Max & Deluxe LAL/AP Mattress System, 5” Air Cells with 3" Foam Cells secondary support

Device Class : 2

Duns Number: 078585060

Premarket Exempt : Yes

Product Code : FNM

Prescription Use : No

Device Count : 1

ArroAir Max & Premier - 00869937000060 Catalog Number :

Device Description : ArroAir Max & Premier LAL/AP Mattress System, 5” Air Cells with 3" Air Cells sec ArroAir Max & Premier LAL/AP Mattress System, 5” Air Cells with 3" Air Cells secondary support

Device Class : 2

Duns Number: 078585060

Premarket Exempt : Yes

Product Code : FNM

Prescription Use : No

Device Count : 1

ArroAir 42" Bariatric AP Mattress System - 00869937000077 Catalog Number :

Device Description : ArroAir 42" Bariatric AP Mattress System including ArroAir Pro Bariatric 14LPM Pump

Device Class : 2

Duns Number: 078585060

Premarket Exempt : Yes

Product Code : FNM

Prescription Use : No

Device Count : 1

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