ARISE MEDICAL LLC

Address:651 WESTMINSTER RD,Wilkes Barre,PA,18702,US

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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

System, Measurement, Blood-Pressure, Non-Invasive (DXN) (4) Nebulizer (Direct Patient Interface) (CAF) (3) Thermometer, Electronic, Clinical (FLL) (2) Lancet, Blood (FMK) (1) Pump, Nebulizer, Electrically Powered (JPW) (1)

Premarket Exempt

No Yes

Clear

Pro-Care Nebulizer Easy - 00372217000013 Catalog Number :

Device Description : Pro-Care Nebulizer Easy

Device Class : 2

Duns Number: 081149273

Premarket Exempt : No

Product Code : CAF

Prescription Use : No

Device Count : 1

UltraCare Blood Lancets - 00372217002017 Catalog Number :

Device Description : UltraCare Blood Lancets - 100 Count

Device Class :

Duns Number: 081149273

Premarket Exempt : Yes

Product Code : FMK

Prescription Use : No

Device Count : 100

ProCare IR Thermometer - 00372217003014 Catalog Number :

Device Description : ProCare IR Thermometer - EFT 161

Device Class : 2

Duns Number: 081149273

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 1

Procare Forehead Infrared Thermometer - 00372217003021 Catalog Number : PG-IRT1602

Device Class : 2

Duns Number: 081149273

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 1

ProCare Automatic Blood Pressure Monitor - Wrist - 00372217004011 Catalog Number :

Device Description : Automatic Arm Blood Pressure Monitor A31

Device Class : 2

Duns Number: 081149273

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

ProCare Automatic Blood Pressure Monitor - Arm - 00372217004028 Catalog Number :

Device Description : ProCare Automatic Blood Pressure Monitor - Arm

Device Class : 2

Duns Number: 081149273

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

Procare Basic Upper Arm BP Monitor - 00372217004035 Catalog Number :

Device Description : Upparm Arm blood pressure monitor with standard cuff

Device Class : 2

Duns Number: 081149273

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

Procare Upper Arm BP Monitor with XL Cuff - 00372217004042 Catalog Number :

Device Description : Procare Upper Arm BP Monitor with XL Cuff

Device Class : 2

Duns Number: 081149273

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

ProCare Nebulizer Basic - 00372217005018 Catalog Number :

Device Description : ProCare Nebulizer Basic

Device Class : 2

Duns Number: 081149273

Premarket Exempt : No

Product Code : CAF

Prescription Use : No

Device Count : 1

Procare Compact Compressor Nebulizer - 00372217005025 Catalog Number :

Device Description : Procare Compact Compressor Nebulizer

Device Class : 1

Duns Number: 081149273

Premarket Exempt : No

Product Code : CAF, JPW

Prescription Use : No

Device Count : 1

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