Home GUDID 00843997017602 Opioid Halo
Primary DI 00843997017602
Brand Opioid Halo
Company MASIMO CORPORATION
Model 4724
Catalog number 4724
Device description Masimo Opioid Halo
Published 2024-08-16
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC true
Sterile false
Single use true Product Codes# Code, Name table Code Name QVT Monitor For Opioid Induced Impairment Of Oxygenation
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class QVT Monitor For Opioid Induced Impairment Of Oxygenation Anesthesiology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00843997017602 Direct Marking GS1 0 00843997016094 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00843997017602 00843997017602 843997017602 0843997017602 00843997016094 00843997016094 843997016094 0843997016094
GMDN Terms# Term, Definition table Term Definition Pulse Co-oximeter probe, single-use 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.
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Humidity 10 Percent (%) Relative Humidity 95 Percent (%) Relative Humidity Handling Environment Temperature 5 Degrees Celsius 40 Degrees Celsius Storage Environment Humidity 10 Percent (%) Relative Humidity 95 Percent (%) Relative Humidity Storage Environment Temperature 0 Degrees Celsius 50 Degrees Celsius
Regulatory Flags# DUNS number 780421038 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit true Combination product false Lot or batch false Serial number true Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex true Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00843997016094 Opioid Halo MASIMO CORPORATION QVT 2024-08-16 00843997016100 Opioid Halo MASIMO CORPORATION QVT 2024-07-10
masimo.com