Test/Blank Sensor in vitro diagnostics device to replace the pO2/pCO2 sensors on the 1200 series instruments


Product Overview

Test/Blank Sensor in vitro diagnostics device to replace the pO2/pCO2 sensors on the 1200 series instruments
TB1 pO2/pCO2 Test/Blank Sensor - 10316620


Device Description

A collection of reagents and other associated materials intended to be used for the quantitative measurement of one or multiple electrolytes in a clinical specimen, using an ion-selective electrode (ISE) method.


Environmental Conditions

No Data Available


Device Sizes

No Data Available


Device Sterilization

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available


Product Codes

Code: CHL

Device Name: Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: CH

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: 862.1120

Third Party Flag: Y

Medical Specialty: CH


Device Identifiers

Device Id: 00630414515250

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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