E-musb MJU101, MODULE ASSEMBLY

E
E-musb - MJU101

Device Description

A small unit dedicated to making communication possible between the patient monitoring system and other independent devices (e.g., ventilator, infusion pump, gas analyser, display monitors) connected to the same patient, creating an interface. It is designed to operate as part of a patient monitoring system enhancing the function of this system (the parent device) by providing connection between disparate devices. It may also be known as a medical information bus protocol.

Environmental Conditions

Handling Environment Atmospheric Pressure - KiloPascal

106.00
70.00

Handling Environment Humidity - Percent (%) Relative Humidity

90.00
10.00

Handling Environment Temperature - Degrees Celsius

40.00
10.00

Storage Environment Atmospheric Pressure - KiloPascal

106.00
50.00

Storage Environment Humidity - Percent (%) Relative Humidity

90.00
10.00

Storage Environment Temperature - Degrees Celsius

60.00
-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: QEM

Device Name: Cerebral Oximeter

Device Class: 2

Physical State: Light radiation transmitter and receiver with associated analytical hardware and software to process the signal

Definition: Oximeter to measure cerebral tissue saturation

Submission Type ID: 1

Review Panel: NE

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Transmits light radiation at known wavelength(s) through blood to measure oxygen saturation based on the amount of reflected or scattered radiation

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Head, Skull, Brain

Regulation Number: 870.2700

Third Party Flag: N

Medical Specialty: CV

Code: MUD

Device Name: Oximeter, Tissue Saturation

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: SU

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: Y

Medical Specialty: CV

Code: CCK

Device Name: Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase

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: 868.1400

Third Party Flag: Y

Medical Specialty: AN

Device Identifiers

Device Id: 00840682145435

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