Vital Sync Weaning Readiness and Spontaneous Breathing Trial Monitoring Application v1 Software with OUS Support

Vital Sync Weaning Readiness and Spontaneous Breathing Trial Monitoring Application v1 Software with OUS Support
Vital Sync - WRSBTSW01

A computerized unit intended to be used with a variety of noninvasive sensors (not included) for the non-continuous measurement of a variety of cardiovascular and pulmonary parameters [e.g., blood pressure, electrocardiography (ECG), SpO2, lung volume, airway resistance]; it might also be intended for additional physiologic analysis [e.g., electromyography (EMG), galvanic skin response (GSR)]. It includes sensor inputs, controls (e.g., touchscreen) and is intended to allow viewing, sharing and storage of the data; it is neither intended for continuous monitoring nor stress exercise monitoring.

No Data Available

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: NSX

Device Name: Software, Transmission And Storage, Patient Data

Device Class: U

Physical State: N/A

Definition: Non-alarming software that captures patient data from patient monitoring devices and transmits the data to the patient electronic medical record, where the data is stored.

Submission Type ID: 3

Review Panel: HO

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: 1

Implant Flag: N

Target Area: N/A

Regulation Number: N/A

Third Party Flag: N

Medical Specialty: N/A

Device Id: 10884521762633

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A