iSpO2 Pulse Oximeter Consumer (Small) - 3589
Device Description
A small unit dedicated to the transcutaneous measurement of haemoglobin oxygen saturation (SpO2) in blood using light detection methods (spectrophotometry) after light is emitted from a light-emitting diode (LED) situated in the connected probe. It is designed to operate as part of a patient monitoring system enhancing the function of this system (the parent device). The module automatically plugs into the parent device when the user places it into a standardized slot in the parent device or a connected module rack. The parent device operates as a mainframe computer displaying the pulse oximetry parameters provided by this module.
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: OCH
Device Name: Oximeter, Infrared, Sporting, Aviation
Device Class: 2
Physical State: sports watch that emits infrared
Definition: Solely for use with sporting and aviation activities. Intended to monitor heart rate during exercise.
Submission Type ID: 7
Review Panel: CV
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: Non-invasive infrared
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: Circulatory pulse
Regulation Number: 870.2700
Third Party Flag: N
Medical Specialty: CV
Code: PGJ
Device Name: Oximeter, Wellness
Device Class: 2
Physical State: Used to transmit light at known wavelengths(s) through blood using a light emitting diode(s) and sensor.
Definition: Pulse oximeter intended for wellness use.
Submission Type ID: 7
Review Panel: AN
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: Transmit light at a known wavelength(s) through blood to measure photoplethysmographic data based on the amount of reflected or scattered light.
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: Circulatory pulse
Regulation Number: 870.2700
Third Party Flag: N
Medical Specialty: CV
Device Identifiers
Device Id: 00843997007726
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