- Physicians Office Resource

Masimo Opioid Halo
Opioid Halo - 4724

Device Description

A photoelectric component of a pulse Co-oximeter that is applied externally to a body part (e.g., a fingertip for adults, the hand or foot for neonates), for the transcutaneous multiwave measurement of carboxy-haemoglobin saturation (SpCO) and typically several other related parameters such as haemoglobin oxygen saturation (SpO2), methaemoglobin saturation (SpMet), haemoglobin concentration (SpHb), haematocrit, and pulse rate using light detection. Signals from the probe, produced by a light-emitting diode (LED) and a receiving detector, are used to calculate results which are digitally displayed on the Co-oximeter's computerized unit. This is a single-use device.

Environmental Conditions

Handling Environment Humidity - Percent (%) Relative Humidity

95.00
10.00

Handling Environment Temperature - Degrees Celsius

40.00
5.00

Storage Environment Humidity - Percent (%) Relative Humidity

95.00
10.00

Storage Environment Temperature - Degrees Celsius

50.00
0.00

Device Sizes

No Data Available

Device Sterilization

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: QVT

Device Name: Monitor For Opioid Induced Impairment Of Oxygenation

Device Class: 2

Physical State: Software/algorithm

Definition: A monitor for opioid induced impairment of oxygenation is a device that uses sensor hardware and software algorithms to detect desaturations of arterial oxygen saturation resulting from opioid overdose

Submission Type ID: 1

Review Panel: AN

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Analyzes physiologic sensor data to detect opioid induced impairment of oxygenation

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Peripheral circulatory pulse

Regulation Number: 868.2250

Third Party Flag: N

Medical Specialty: AN

Device Identifiers

Device Id: 00843997017602

Device Type: Direct Marking

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: 00843997016094

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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