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) (3) Electrode, Cutaneous (GXY) (2) Mask, Oxygen (BYG) (2) Nebulizer, Medicinal, Non-Ventilatory (Atomizer) (CCQ) (2) Blood Pressure Cuff (DXQ) (1)

Premarket Exempt

No Yes

Clear

Omron A.I.R..S. Nebulizer - 00073796099114 Catalog Number : 9911

Device Description : Nebulizer

Device Class :

Duns Number: 054318779

Premarket Exempt : No

Product Code : CCQ

Prescription Use : Yes

Device Count : 1

Omron A.I.R.S.Disposable Nebulizer Kit - 00073796099121 Catalog Number : 9912

Device Description : .Disposable Nebulizer Kit with Filter

Device Class :

Duns Number: 054318779

Premarket Exempt : No

Product Code : CCQ

Prescription Use : Yes

Device Count : 1

Omron A.I.R.S. Adult Aerosol Mask - 00073796099206 Catalog Number : 9920

Device Description : Omron A.I.R.S. Adult Aerosol Mask

Device Class :

Duns Number: 054318779

Premarket Exempt : Yes

Product Code : BYG

Prescription Use : Yes

Device Count : 1

Omron Aerosol Mask - 00073796099213 Catalog Number : 9921

Device Description : Pediatric Aerosol Mask

Device Class :

Duns Number: 054318779

Premarket Exempt : Yes

Product Code : BYG

Prescription Use : Yes

Device Count : 1

Omron 3 Series Upper Arm Blood Pressure Monitor - 00073796100315 Catalog Number : BP7100CAN

Device Description : 3 Series upper arm blood pressure monitor with 14 memory storage and wide range 3 Series upper arm blood pressure monitor with 14 memory storage and wide range cuff. Easy one-touch operation.

Device Class :

Duns Number: 054318779

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

Aneroid Sphygmomanometer - 00073796112004 Catalog Number :

Device Description : Aneroid Sphygmomanometer with Blue Nylon Cuff

Device Class :

Duns Number: 054318779

Premarket Exempt : No

Product Code : DXQ

Prescription Use : No

Device Count : 1

Focus Knee Replacement Band - Large - 00073796124427 Catalog Number : PMKBAND-L

Device Description : Replacement Band for Omron Focus TENS unit - Large

Device Class : 2

Duns Number: 054318779

Premarket Exempt : No

Product Code : GXY

Prescription Use : No

Device Count : 1

Focus Knee Replacement Band - Medium - 00073796124434 Catalog Number : PMKBAND-M

Device Description : Replacement band for the Omron Focus TENS Unit - Medium

Device Class : 2

Duns Number: 054318779

Premarket Exempt : No

Product Code : GXY

Prescription Use : No

Device Count : 1

1.3 Meter Air Tube Asssembly for HEM-907XL - 00073796130428 Catalog Number : HEM-TUBE-130XL

Device Description : Air Tube for Blood Pressure Monitor HEM-907XL

Device Class :

Duns Number: 054318779

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

AC Adapter for digital Blood Pressure Units - 00073796146054 Catalog Number : HEM-ADPTW5

Device Description : AC Adapter

Device Class :

Duns Number: 054318779

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

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