Medex

Medex - MX858P1

A sterile, noninvasive, non-luminal, electronic device designed to be connected to an appropriate invasive luminal device (e.g., catheter, cannula, tube, needle), to detect pressures (e.g., blood, gastrointestinal, urinary pressures) within the lumen and transmit them as electrical signals to an appropriate monitoring device. It consists of a pressure transducer and a connection cable and may be designed to be used with a pressure transducer dome. This is a single-use device.

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No Data Available

Device Sterile: True

Sterilization Prior To Use: True

Sterilization Methods:

• Ethylene Oxide

Code: DRS

Device Name: Transducer, Blood-Pressure, Extravascular

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: 870.2850

Third Party Flag: Y

Medical Specialty: CV

Device Id: 50351688504669

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 10351688504661

Package Quantity: 50

Package Discontinue Date: 8/13/2019 12:00:00 AM

Package Status: Not in Commercial Distribution

Package Type: Case

Device Id: 10351688504661

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