Home GUDID 07640149380767 imtmedical
Primary DI 07640149380767
Brand imtmedical
Company imtmedical ag
Model 301.328.010
Catalog number 301.328.010
Device description iFlow 200 S Adult/Pediatric Proximal Flow Sensor
Published 2021-01-13
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use true Product Codes# Code, Name table Code Name BZO SET, TUBING AND SUPPORT, VENTILATOR (W HARNESS) CBK Ventilator, Continuous, Facility Use
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class BZO Set, Tubing And Support, Ventilator (W Harness) Anesthesiology 1 CBK Ventilator, Continuous, Facility Use Anesthesiology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 07640149380767 Package GS1 10 In Commercial Distribution 07640149381344 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 07640149380767 07640149380767 7640149380767 07640149381344 07640149381344 7640149381344
GMDN Terms# Term, Definition table Term Definition Breathing circuit gas-sampling/monitoring set A collection of non-sterile devices intended to be integrated within a breathing circuit to enable interface of gases between the breathing circuit and a respiratory monitoring device for sampling the patient's expired gas for measurements of pressure, flow and/or gas analysis [e.g., end-tidal carbon dioxide (EtCO2) concentration]. It includes both a tube/mask breathing circuit connector with sampling ports (sometimes referred to as a spirometry sensor) and gas-sampling/monitoring respiratory tubing; no electronic devices are included. This is a single-use device.
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Keep away from sunlight Special Storage Condition, Specify 0 0 Keep Dry Storage Environment Humidity 10 Percent (%) Relative Humidity 90 Percent (%) Relative Humidity Storage Environment Temperature -20 Degrees Celsius 50 Degrees Celsius
Regulatory Flags# DUNS number 483243700 Device count 1 DM exempt false Premarket exempt true HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label true Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes# 
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