SpO2 probe Child / Infant (from 3 to 20 kg) Finger or toe, disposable


Product Overview

SpO2 probe Child / Infant (from 3 to 20 kg) Finger or toe, disposable
BluPRO® - TL-274T3


Device Description

A photoelectric device designed to be applied externally to a body site (e.g., fingertip, ear lobe, bridge of nose, toe, or bridge of the foot) for the transcutaneous measurement of haemoglobin oxygen saturation (SpO2) in arterial blood using signals produced by a light-emitting diode (LED) and received by a photodetector. The signals are subsequently transmitted to an oximeter/monitor (not included) which measures and displays the SpO2. The is a single-use device.


Environmental Conditions

No Data Available


Device Sizes

  • Pediatric
    • Pediatric


    Device Sterilization

    Device Sterile: False

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: DRT

    Device Name: Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)

    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: GWQ

    Device Name: Full-Montage Standard Electroencephalograph

    Device Class: 2

    Physical State: May include standard electroencephalograph recording hardware (e.g. headbox, cables, computer, monitor, wireless) and basic software (e.g. used to display, store, archive, or manually annotate data). Does NOT include electrodes, more complex software used to analyze electroencephalograph data or automatically detect events, electroencephalograph used for polysomnography or sleep studies, or electroencephalograph with less than 16 electrodes.

    Definition: Acquire, display, store, and archive electroencephalographic signals from the brain using a full montage array (i.e., 16 or more electrodes) and user-specified locations

    Submission Type ID: 1

    Review Panel: NE

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: Uses electrodes (16 or more) placed on the scalp or within the brain, via user-specified locations, to record and display electrical activity of the brain

    Life Sustain Support Flag: N

    Unclassified Reason: N/A

    Implant Flag: N

    Target Area: Brain

    Regulation Number: 882.1400

    Third Party Flag: Y

    Medical Specialty: NE


    Code: MHX

    Device Name: Monitor, Physiological, Patient(With 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: 870.1025

    Third Party Flag: N

    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


    Device Identifiers

    Device Id: 10841983102742

    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


    Device Id: 00841983102745

    Device Type: Unit of Use

    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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