Home GUDID 04035324019304 TRACOE vario
Primary DI 04035324019304
Brand TRACOE vario
Company Tracoe medical GmbH
Model REF 461-08-P
Catalog number REF 461-08-P
Device description TRACOE vario XL Tracheostomy Tube, Extra-Long, with Adjustable Neck Flange and Low Pressure Cuff, with minimally traumatic insertion system
Published 2021-08-19
Public version status Update
Distribution status In Commercial Distribution
MRI safety MR Conditional
Rx true
Sterile true Product Codes# Code, Name table Code Name JOH Tube Tracheostomy And Tube Cuff
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class JOH Tube Tracheostomy And Tube Cuff Anesthesiology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 04035324019304 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 04035324019304 04035324019304 4035324019304
GMDN Terms# Term, Definition table Term Definition Tracheostomy tube, non-reinforced, non-customized, single-use A hollow cylinder designed to be inserted into an artificial opening made in the trachea (windpipe) during a tracheotomy to provide a patent airway; it is not custom-made for a specific patient and is not reinforced with a wire. It is typically constructed of plastic and may include an inner cannula. It is available in cuffed, uncuffed, and/or fenestrated versions, and in a variety of shapes and sizes. It is typically secured in position by a tracheostomy tube holder fastened around the patient's neck. This is a single-use device.
Device Sizes# Type, Value, Unit table Type Value Unit Lumen/Inner Diameter 8 Millimeter
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Keep away from rain. Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize. Special Storage Condition, Specify 0 0 Store in a dry place, Protect from sunlight, Storage temperature limits: 10-40°C Storage Environment Temperature 10 Degrees Celsius 40 Degrees Celsius
Regulatory Flags# DUNS number 319414785 Device count 1 Lot or batch true Expiration date on label true No natural rubber latex true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 10887709204192 Bivona ICU MEDICAL, INC. JOH 2026-09-25 10887709204451 Bivona ICU MEDICAL, INC. JOH 2026-09-25 10887709204734 Bivona ICU MEDICAL, INC. JOH 2026-09-25 10887709204901 Bivona ICU MEDICAL, INC. JOH 2026-09-25 10887709204918 Bivona ICU MEDICAL, INC. JOH 2026-09-25 10887709204925 Bivona ICU MEDICAL, INC. JOH 2026-09-25 10887709204932 Bivona ICU MEDICAL, INC. JOH 2026-09-25 10887709204949 Bivona ICU MEDICAL, INC. JOH 2026-09-25 10887709204826 Bivona ICU MEDICAL, INC. JOH 2026-09-24 10887709204833 Bivona ICU MEDICAL, INC. JOH 2026-09-24 10887709204840 Bivona ICU MEDICAL, INC. JOH 2026-09-24 10887709204857 Bivona ICU MEDICAL, INC. JOH 2026-09-24 10887709204864 Bivona ICU MEDICAL, INC. JOH 2026-09-24 10887709204871 Bivona ICU MEDICAL, INC. JOH 2026-09-24 10887709204888 Bivona ICU MEDICAL, INC. JOH 2026-09-24 10887709204895 Bivona ICU MEDICAL, INC. JOH 2026-09-24 10887709204505 Bivona ICU MEDICAL, INC. JOH 2026-09-22 10887709204512 Bivona ICU MEDICAL, INC. JOH 2026-09-22 10887709204550 Bivona ICU MEDICAL, INC. JOH 2026-09-22 10887709204680 Bivona ICU MEDICAL, INC. JOH 2026-09-22 10887709204697 Bivona ICU MEDICAL, INC. JOH 2026-09-22 10887709204703 Bivona ICU MEDICAL, INC. JOH 2026-09-22 10887709204710 Bivona ICU MEDICAL, INC. JOH 2026-09-22 10887709204727 Bivona ICU MEDICAL, INC. JOH 2026-09-22 10887709204741 Bivona ICU MEDICAL, INC. JOH 2026-09-22 10887709204475 Bivona ICU MEDICAL, INC. JOH 2026-09-21 10887709204482 Bivona ICU MEDICAL, INC. JOH 2026-09-21 10887709204574 Bivona ICU MEDICAL, INC. JOH 2026-09-21 10887709204581 Bivona ICU MEDICAL, INC. JOH 2026-09-21 10887709204598 Bivona ICU MEDICAL, INC. JOH 2026-09-21
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