Omron Healthcare, Inc.

Address:2895 Greenspoint Parkway,Hoffman Est,IL,60169,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) (6) Nebulizer (Direct Patient Interface) (CAF) (3) Stimulator, Electrical, Transcutaneous, For Arthritis (NYN) (1) Stimulator, Nerve, Transcutaneous, Over-The-Counter (NUH) (1)

Premarket Exempt

No Yes

Clear

7 Series Plus Bluetooth Smart Blood Pressure Monitor - 00073796761431 Catalog Number :

Device Class :

Duns Number: 054318779

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

Blood Pressure Monitor - 00073796765316 Catalog Number : BP765CAN-CD6

Device Description : Omron Blood Pressure Monitor

Device Class :

Duns Number: 054318779

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

Omron Blood Pressure Monitor - 00073796769314 Catalog Number : BP769CAN

Device Description : Digital Upper Arm Blood Pressure Monitor with 9" to 17" Easy-Wrap Cuff

Device Class : 2

Duns Number: 054318779

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

10 Series Plus Bluetooth Smart Blood Pressure Monitor - 00073796786342 Catalog Number : BP786CANN

Device Description : Omron 10 Series Blood Pressure Monitor with Bluetooth

Device Class :

Duns Number: 054318779

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

Omron CompAir Compressor Nebulizer - 00073796800147 Catalog Number : RE-C800KD

Device Description : Omron compressor nebulizer, with nebulizer kit and pediatric mask.

Device Class : 2

Duns Number: 054318779

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

Omron TENS Total Power + Heat for Canada - 00073796800314 Catalog Number : PM800CAN

Device Description : Omron TENS Total Power + Heat is a portable, battery-operated device that is des Omron TENS Total Power + Heat is a portable, battery-operated device that is designed to relieve muscle and joint pain.

Device Class : 2

Duns Number: 054318779

Premarket Exempt : No

Product Code : NYN, NUH

Prescription Use : No

Device Count : 1

Large D-ring Cuff for Digital Blood Pressure Monitor - 00073796800345 Catalog Number : H-003D

Device Description : Cuff for Blood Pressure Monitor

Device Class :

Duns Number: 054318779

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

Small D-Ring Arm Cuff for Digital Blood Pressure Monitor - 00073796800369 Catalog Number : H-003DS

Device Description : Small D-ring Blood Pressure Cuff

Device Class :

Duns Number: 054318779

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

Omron Air Tube - 00073796801106 Catalog Number : C801AT

Device Description : Air Tube for use with Nebulizer Kit

Device Class :

Duns Number: 054318779

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

Omron Nebulizer Kit with Air Tube and Mouthpiece - 00073796801458 Catalog Number : C801NEB

Device Description : Nebulizer Kit with Air Tube and Mouthpiece for NE-C801

Device Class :

Duns Number: 054318779

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

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