- Physicians Office Resource

SENSOR BATTERY DEVICE ASSEMBLY
PORTRAIT SBT01 - SBT01

Device Description

An electrically-powered device intended to receive data relating to multiple vital physiological parameters [e.g., electrocardiogram (ECG), noninvasive blood pressure (NIBP), pulse rate, temperature, haemoglobin oxygen saturation (SpO2)] from an appropriate sensor, and wirelessly transmit the data to a parent device (e.g., monitor and/or an off-the-shelf computer/tablet) with appropriate software installed; it may in addition be intended to provide electrical energy to the connected probe/electrode.

Environmental Conditions

Storage Environment Atmospheric Pressure - KiloPascal

106.00
50.00

Storage Environment Humidity - Percent (%) Relative Humidity

95.00
5.00

Storage Environment Temperature - Degrees Celsius

40.00
-20.00

Device Sizes

No Data Available

Device Sterilization

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: BZQ

Device Name: Monitor, Breathing Frequency

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: AN

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 868.2375

Third Party Flag: Y

Medical Specialty: AN

Code: MWI

Device Name: Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: CV

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 870.2300

Third Party Flag: Y

Medical Specialty: CV

Code: DRG

Device Name: Transmitters And Receivers, Physiological Signal, Radiofrequency

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: CV

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 870.2910

Third Party Flag: Y

Medical Specialty: CV

Code: MSX

Device Name: System, Network And Communication, Physiological Monitors

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: CV

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: Y

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 870.2300

Third Party Flag: N

Medical Specialty: CV

Code: DQA

Device Name: Oximeter

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: AN

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 870.2700

Third Party Flag: N

Medical Specialty: CV

Device Identifiers

Device Id: 00195278366085

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 00195278120014

Package Quantity: 2

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: N/A

Device Id: 00195278120014

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

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