Home GUDID 07350061231183 SPIRO
Primary DI 07350061231183
Brand SPIRO
Company Fogless International AB
Model 711
Catalog number 711-1K; 711-2K; 711-5K;
Device description SPIRO Speaking Valve (without oxygen nipple)
Published 2018-03-31
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx 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 07350061231206 Package GS1 2 In Commercial Distribution 07350061231213 Package GS1 5 In Commercial Distribution 07350061231374 Package GS1 1 In Commercial Distribution 07350061231183 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 07350061231206 07350061231206 7350061231206 07350061231213 07350061231213 7350061231213 07350061231374 07350061231374 7350061231374 07350061231183 07350061231183 7350061231183
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.
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Store in a dark and dry environment at normal indoor room temperature
Regulatory Flags# DUNS number 356432815 Device count 1 DM exempt true Lot or batch true Expiration date on label true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 10887709201016 Bivona ICU MEDICAL, INC. JOH 2026-08-19 10887709201450 Bivona ICU MEDICAL, INC. JOH 2026-08-19 10887709201504 Bivona ICU MEDICAL, INC. JOH 2026-08-19 10887709201528 Bivona ICU MEDICAL, INC. JOH 2026-08-19 10887709201535 Bivona ICU MEDICAL, INC. JOH 2026-08-19 10887709201542 Bivona ICU MEDICAL, INC. JOH 2026-08-19 10887709201559 Bivona ICU MEDICAL, INC. JOH 2026-08-19 10887709201566 Bivona ICU MEDICAL, INC. JOH 2026-08-19 10887709201573 Bivona ICU MEDICAL, INC. JOH 2026-08-19 10887709201603 Bivona ICU MEDICAL, INC. JOH 2026-08-19 10887709201610 Bivona ICU MEDICAL, INC. JOH 2026-08-19 10887709201351 Bivona ICU MEDICAL, INC. JOH 2026-08-18 10887709201368 Bivona ICU MEDICAL, INC. JOH 2026-08-18 10887709201375 Bivona ICU MEDICAL, INC. JOH 2026-08-18 10887709201399 Bivona ICU MEDICAL, INC. JOH 2026-08-18 10887709201405 Bivona ICU MEDICAL, INC. JOH 2026-08-18 10887709201412 Bivona ICU MEDICAL, INC. JOH 2026-08-18 10887709201429 Bivona ICU MEDICAL, INC. JOH 2026-08-18 10887709201436 Bivona ICU MEDICAL, INC. JOH 2026-08-18 10887709201443 Bivona ICU MEDICAL, INC. JOH 2026-08-18 10887709200873 Bivona ICU MEDICAL, INC. JOH 2026-08-17 10887709200880 Bivona ICU MEDICAL, INC. JOH 2026-08-17 10887709200897 Bivona ICU MEDICAL, INC. JOH 2026-08-17 10887709200903 Bivona ICU MEDICAL, INC. JOH 2026-08-17 10887709200910 Bivona ICU MEDICAL, INC. JOH 2026-08-17 10887709200927 Bivona ICU MEDICAL, INC. JOH 2026-08-17 10887709200941 Bivona ICU MEDICAL, INC. JOH 2026-08-17 10887709200958 Bivona ICU MEDICAL, INC. JOH 2026-08-17 10887709200965 Bivona ICU MEDICAL, INC. JOH 2026-08-17 10887709200972 Bivona ICU MEDICAL, INC. JOH 2026-08-17
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