INS R95198
BioTrend® - R95198-04
Device Description
A mains electricity (AC-powered) device designed for the continuous measurement and display of blood gas and related parameters when blood is circulated outside of the body in a closed system. It is typically used with an appropriate sensor or sensor cassette inserted into external tubing to measure parameters such as partial pressure of oxygen (pO2), partial pressure of carbon dioxide (pCO2), pH, temperature, haemoglobin (Hb), and hematocrit (Hct). It is typically used with a cardiopulmonary bypass system, or bedside for a patient with respiratory failure (e.g., obstructive lung disease, severe asthma) or severe pulmonary hypertension after cardiac surgery.
Environmental Conditions
- The device should only be used in a hospital environment away from sources of high-intensity electromagnetic disturbances, such as MRI devices.
- 101.00
- 73.00
- 95.00
- 5.00
- 65.00
- -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: DTY
Device Name: Sensor, Blood-Gas, In-Line, Cardiopulmonary Bypass
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: 870.4410
Third Party Flag: Y
Medical Specialty: CV
Device IdentifiersDevice Id: 00763000216269
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