Home GUDID 07350061231237 SPIRO
Primary DI 07350061231237
Brand SPIRO
Company Fogless International AB
Model 730
Catalog number 730-10
Device description Shower Protection for SPIRO Speaking Valve models 710,710R,711
Published 2018-03-31
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use false 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 07350061231237 Package GS1 5 In Commercial Distribution 07350061231411 Package GS1 2 In Commercial Distribution 07350061231220 Primary GS1 0 07350061231343 Unit of Use GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 07350061231237 07350061231237 7350061231237 07350061231411 07350061231411 7350061231411 07350061231220 07350061231220 7350061231220 07350061231343 07350061231343 7350061231343
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 2 DM exempt true Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false 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# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 10887709207919 Bivona ICU MEDICAL, INC. JOH 2026-10-29 10887709207926 Bivona ICU MEDICAL, INC. JOH 2026-10-29 10887709207735 Bivona ICU MEDICAL, INC. JOH 2026-10-28 10887709207742 Bivona ICU MEDICAL, INC. JOH 2026-10-28 10887709207759 Bivona ICU MEDICAL, INC. JOH 2026-10-28 10887709207766 Bivona ICU MEDICAL, INC. JOH 2026-10-28 10887709207773 Bivona ICU MEDICAL, INC. JOH 2026-10-28 10887709207780 Bivona ICU MEDICAL, INC. JOH 2026-10-28 10887709207797 Bivona ICU MEDICAL, INC. JOH 2026-10-28 10887709207803 Bivona ICU MEDICAL, INC. JOH 2026-10-28 10887709207810 Bivona ICU MEDICAL, INC. JOH 2026-10-28 10887709207827 Bivona ICU MEDICAL, INC. JOH 2026-10-28 10887709207834 Bivona ICU MEDICAL, INC. JOH 2026-10-28 10887709207841 Bivona ICU MEDICAL, INC. JOH 2026-10-28 10887709207858 Bivona ICU MEDICAL, INC. JOH 2026-10-28 10887709207865 Bivona ICU MEDICAL, INC. JOH 2026-10-28 10887709207872 Bivona ICU MEDICAL, INC. JOH 2026-10-28 10887709207285 Bivona ICU MEDICAL, INC. JOH 2026-10-27 10887709207292 Bivona ICU MEDICAL, INC. JOH 2026-10-27 10887709207308 Bivona ICU MEDICAL, INC. JOH 2026-10-27 10887709207315 Bivona ICU MEDICAL, INC. JOH 2026-10-27 10887709207322 Bivona ICU MEDICAL, INC. JOH 2026-10-27 10887709207445 Bivona ICU MEDICAL, INC. JOH 2026-10-27 10887709207452 Bivona ICU MEDICAL, INC. JOH 2026-10-27 10887709207469 Bivona ICU MEDICAL, INC. JOH 2026-10-27 10887709207476 Bivona ICU MEDICAL, INC. JOH 2026-10-27 10887709207483 Bivona ICU MEDICAL, INC. JOH 2026-10-27 10887709207490 Bivona ICU MEDICAL, INC. JOH 2026-10-27 10887709207506 Bivona ICU MEDICAL, INC. JOH 2026-10-27 10887709207513 Bivona ICU MEDICAL, INC. JOH 2026-10-27