Home GUDID 04035324054510
TRACOE® modular
Primary DI 04035324054510
Brand TRACOE® modular
Company Tracoe medical GmbH
Model REF 650-S
Device description TRACOE phon assist I
Published 2015-10-18
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Sterile true
Single use 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 04035324054510 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 04035324054510 04035324054510 4035324054510
GMDN Terms# Term, Definition table Term Definition Tracheostomy tube speech valve A device designed to be attached to a tracheostomy tube to eliminate the necessity of finger occlusion during speech, enabling the tracheostomized patient to speak easily and more clearly. It is typically intended to be regularly attached and removed by the patient (e.g., before and after sleeping). It may be made of metal [e.g., silver (Ag)] or plastic materials, and some types may have a sideport for connection to an oxygen supply. This is a single-patient device that may be reapplied over a period of time before being discarded.
Device Sizes# Type, Value, Unit table Type Value Unit Device Size Text, specify 0
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Products must be stored in cool and dry location.
Temporary storage for less or equal to 30 days at less or equal to +50 °C is possible. Protect product from sunlight and extreme cold. Special Storage Condition, Specify 0 0 Products must be stored in cool and dry location.Temporary storage for less or equal to 30 days at less or equal to +50 °C is possible. Protect product from sunlight and extreme cold.
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 10887709197265 Bivona ICU MEDICAL, INC. JOH 2026-07-09 10887709197289 Bivona ICU MEDICAL, INC. JOH 2026-07-09 10887709197838 Bivona ICU MEDICAL, INC. JOH 2026-07-09 10887709197845 Bivona ICU MEDICAL, INC. JOH 2026-07-09 10887709197852 Bivona ICU MEDICAL, INC. JOH 2026-07-09 10887709197869 Bivona ICU MEDICAL, INC. JOH 2026-07-09 10887709197876 Bivona ICU MEDICAL, INC. JOH 2026-07-09 10887709197883 Bivona ICU MEDICAL, INC. JOH 2026-07-09 10887709197890 Bivona ICU MEDICAL, INC. JOH 2026-07-09 10887709197906 Bivona ICU MEDICAL, INC. JOH 2026-07-09 10887709197135 Bivona ICU MEDICAL, INC. JOH 2026-07-08 10887709197142 Bivona ICU MEDICAL, INC. JOH 2026-07-08 10887709197203 Bivona ICU MEDICAL, INC. JOH 2026-07-08 10887709197210 Bivona ICU MEDICAL, INC. JOH 2026-07-08 10887709197227 Bivona ICU MEDICAL, INC. JOH 2026-07-08 10887709197234 Bivona ICU MEDICAL, INC. JOH 2026-07-08 10887709197241 Bivona ICU MEDICAL, INC. JOH 2026-07-08 10887709197722 Bivona ICU MEDICAL, INC. JOH 2026-07-08 10887709197739 Bivona ICU MEDICAL, INC. JOH 2026-07-08 10887709197746 Bivona ICU MEDICAL, INC. JOH 2026-07-08 10887709197753 Bivona ICU MEDICAL, INC. JOH 2026-07-08 10887709197760 Bivona ICU MEDICAL, INC. JOH 2026-07-08 10887709197777 Bivona ICU MEDICAL, INC. JOH 2026-07-08 10887709197784 Bivona ICU MEDICAL, INC. JOH 2026-07-08 10887709197791 Bivona ICU MEDICAL, INC. JOH 2026-07-08 10887709197807 Bivona ICU MEDICAL, INC. JOH 2026-07-08 10887709197586 Bivona ICU MEDICAL, INC. JOH 2026-07-07 10887709197593 Bivona ICU MEDICAL, INC. JOH 2026-07-07 10887709197609 Bivona ICU MEDICAL, INC. JOH 2026-07-07 10887709197616 Bivona ICU MEDICAL, INC. JOH 2026-07-07