Sotera Wireless, Inc.

Address:5841 Edison Place,Carlsbad,CA,92008,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) (8) Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) (MHX) (3) Detector And Alarm, Arrhythmia (DSI) (1) Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) (MWI) (1) Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms) (MWI) (1) Oximeter (DQA) (1)

Premarket Exempt

Clear

ViSi - 00850733007261 Catalog Number : 94-10192

Device Description : Disposable Adult Cuff, Large (Qty 20)

Device Class : 2

Duns Number: 167142491

Premarket Exempt : No

Product Code : DXN

Prescription Use : Yes

Device Count : 20

ViSi - 00850733007285 Catalog Number : 94-10193

Device Description : Disposable Adult Cuff, Large+ (Qty 20)

Device Class : 2

Duns Number: 167142491

Premarket Exempt : No

Product Code : DXN

Prescription Use : Yes

Device Count : 20

ViSi - 00850733007322 Catalog Number : 94-10172

Device Description : Disposable Wrist Cradle, Small (Qty 20)

Device Class : 2

Duns Number: 167142491

Premarket Exempt : No

Product Code : DXN

Prescription Use : Yes

Device Count : 20

ViSi - 00850733007346 Catalog Number : 94-10173

Device Description : Disposable Wrist Cradle, Medium (Qty 20)

Device Class : 2

Duns Number: 167142491

Premarket Exempt : No

Product Code : DXN

Prescription Use : Yes

Device Count : 20

ViSi - 00850733007360 Catalog Number : 94-10174

Device Description : Disposable Wrist Cradle, Large (Qty 20)

Device Class : 2

Duns Number: 167142491

Premarket Exempt : No

Product Code : DXN

Prescription Use : Yes

Device Count : 20

ViSi - 00850733007377 Catalog Number : 92-10022

Device Description : ViSi Mobile Charger, 2-Bay

Device Class : 2

Duns Number: 167142491

Premarket Exempt : No

Product Code : DXN, MHX

Prescription Use : Yes

Device Count : 1

ViSi - 00850733007384 Catalog Number : 92-10023

Device Description : ViSi Mobile Charger, 8-Bay

Device Class : 2

Duns Number: 167142491

Premarket Exempt : No

Product Code : DXN, MHX

Prescription Use : Yes

Device Count : 1

ViSi - 00850733007407 Catalog Number : 94-10195

Device Description : Chest Sensor Securements (Qty 100)

Device Class :

Duns Number: 167142491

Premarket Exempt : No

Product Code : MWI

Prescription Use : Yes

Device Count : 100

ViSi - 00850733007414 Catalog Number : 97-10259

Device Description : ViSi Emergency Medical Surveillance (EMS) Kit

Device Class : 2

Duns Number: 167142491

Premarket Exempt : No

Product Code : DXN, MWI, DSI, MHX

Prescription Use : Yes

Device Count : 1

ViSi - 10850733007183 Catalog Number : 94-10007

Device Description : Thumb Tape (Qty 100)

Device Class : 2

Duns Number: 167142491

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 100

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