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 10887709195131 Bivona ICU MEDICAL, INC. JOH 2026-06-08 10887709195148 Bivona ICU MEDICAL, INC. JOH 2026-06-08 10887709195155 Bivona ICU MEDICAL, INC. JOH 2026-06-08 10887709195162 Bivona ICU MEDICAL, INC. JOH 2026-06-08 10887709195179 Bivona ICU MEDICAL, INC. JOH 2026-06-08 10887709195186 Bivona ICU MEDICAL, INC. JOH 2026-06-08 10887709195193 Bivona ICU MEDICAL, INC. JOH 2026-06-08 10887709195209 Bivona ICU MEDICAL, INC. JOH 2026-06-08 10887709195216 Bivona ICU MEDICAL, INC. JOH 2026-06-08 10887709195223 Bivona ICU MEDICAL, INC. JOH 2026-06-08 10887709195230 Bivona ICU MEDICAL, INC. JOH 2026-06-08 10887709195247 Bivona ICU MEDICAL, INC. JOH 2026-06-08 10887709195254 Bivona ICU MEDICAL, INC. JOH 2026-06-08 10887709195261 Bivona ICU MEDICAL, INC. JOH 2026-06-08 10887709195278 Bivona ICU MEDICAL, INC. JOH 2026-06-08 10887709194967 Bivona ICU MEDICAL, INC. JOH 2026-06-05 10887709194974 Bivona ICU MEDICAL, INC. JOH 2026-06-05 10887709194981 Bivona ICU MEDICAL, INC. JOH 2026-06-05 10887709194998 Bivona ICU MEDICAL, INC. JOH 2026-06-05 10887709195001 Bivona ICU MEDICAL, INC. JOH 2026-06-05 10887709195018 Bivona ICU MEDICAL, INC. JOH 2026-06-05 10887709195025 Bivona ICU MEDICAL, INC. JOH 2026-06-05 10887709195032 Bivona ICU MEDICAL, INC. JOH 2026-06-05 10887709195049 Bivona ICU MEDICAL, INC. JOH 2026-06-05 10887709195056 Bivona ICU MEDICAL, INC. JOH 2026-06-05 10887709195063 Bivona ICU MEDICAL, INC. JOH 2026-06-05 10887709195070 Bivona ICU MEDICAL, INC. JOH 2026-06-05 10887709195087 Bivona ICU MEDICAL, INC. JOH 2026-06-05 10887709195094 Bivona ICU MEDICAL, INC. JOH 2026-06-05 10887709195100 Bivona ICU MEDICAL, INC. JOH 2026-06-05