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) (5) Stimulator, Nerve, Transcutaneous, Over-The-Counter (NUH) (3) Nebulizer (Direct Patient Interface) (CAF) (2) Stimulator, Electrical, Transcutaneous, For Arthritis (NYN) (1)

Premarket Exempt

No Yes

Clear

AC Adapter for NE-C30 - 00073796330132 Catalog Number :

Device Class :

Duns Number: 054318779

Premarket Exempt : No

Product Code : CAF

Prescription Use : No

Device Count : 1

Omron Pain Relief Pro - 00073796330316 Catalog Number : PM3031

Device Description : Electrotherapy Pain Relief TENS Unit

Device Class :

Duns Number: 054318779

Premarket Exempt : No

Product Code : NUH

Prescription Use : No

Device Count : 1

Omron Max Power Relief - 00073796330323 Catalog Number : PM3032

Device Description : Electrotherapy Pain Relief TENS Unit

Device Class :

Duns Number: 054318779

Premarket Exempt : No

Product Code : NUH

Prescription Use : No

Device Count : 1

Omron Air Filters for NE-C30 - 00073796330620 Catalog Number : C30FL

Device Description : Air Filters for NE-C30 Nebulizer

Device Class :

Duns Number: 054318779

Premarket Exempt : No

Product Code : CAF

Prescription Use : No

Device Count : 5

Omron Wide Range D-ring Cuff - 00073796341725 Catalog Number : HEM-RML31-B

Device Description : Optional Cuff (9" to 17") for Omron Digital Blood Pressure Monitor

Device Class : 2

Duns Number: 054318779

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

Large D-ring Cuff for Digital Blood Pressure Monitor - 00073796343149 Catalog Number : H-003DCAN

Device Description : Blood Pressure Cuff for Blood Pressure Monitor (Large D-ring)

Device Class :

Duns Number: 054318779

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

Wide Range D-Ring Cuff 9" to 17" - 00073796343170 Catalog Number : CD-WR17

Device Description : Contoured wide range Blood Pressure Cuff 9" to 17"

Device Class :

Duns Number: 054318779

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

Omron Small D-ring Cuff - 00073796343927 Catalog Number : HEM-CS24-B

Device Description : Optional Cuff (7" to 9") for Omron Digital Blood Pressure Monitor

Device Class : 2

Duns Number: 054318779

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

Countoured Small Arm Cuff 7"-9" - 00073796343996 Catalog Number : CD-CS9

Device Description : Contoured Small Arm Blood Pressure Cuff

Device Class :

Duns Number: 054318779

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

Avail Wireless Pad - 00073796346140 Catalog Number : PMWPAD-M

Device Description : Medium Pad for Avail wireless TENS device PM601

Device Class : 2

Duns Number: 054318779

Premarket Exempt : No

Product Code : NYN, NUH

Prescription Use : No

Device Count : 1

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