Home GUDID 07331791016349 Provox Luna HME
Primary DI 07331791016349
Brand Provox Luna HME
Company Atos Medical AB
Model 8013
Catalog number 8013
Device description The Provox Luna HME is a single use heat- and moisture exchanger, attachable to the Provox Luna Adhesive, for night-time use after total laryngectomy.
Published 2022-11-24
Public version status New
Distribution status In Commercial Distribution
MRI safety MR Safe
Rx false
OTC true
Sterile false
Single use true Product Codes# Code, Name table Code Name BYD Condenser, Heat And Moisture (Artificial Nose) KGX Tape And Bandage, Adhesive
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class BYD Condenser, Heat And Moisture (Artificial Nose) Anesthesiology 1 KGX Tape And Bandage, Adhesive General Hospital 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 07331791017780 Package GS1 30 In Commercial Distribution 07331791009242 Primary GS1 0 07331791015700 Primary GS1 0 07331791016349 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 07331791017780 07331791017780 7331791017780 07331791009242 07331791009242 7331791009242 07331791015700 07331791015700 7331791015700 07331791016349 07331791016349 7331791016349
GMDN Terms# Term, Definition table Term Definition Tracheostoma protective filter A non-sterile device designed as a filter for protecting a stomal opening in the windpipe (surgically-created artificial opening between the trachea and the body surface through which the patient can breathe) against harmful external influences. It may also function as a heat & moisture exchanger (HME) intended to capture the patient's exhaled breath so that it can be used to warm and moisten inspired air to help keep the trachea lubricated and prevent its mucosa from drying. It is typically designed as a hydrophobic foam filter of various sizes held in place with an adhesive strip. This is a single-use device changed regularly according to the manufacturer's instructions.
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. Special Storage Condition, Specify 0 0 Keep dry. Keep away from sunlight Storage Environment Temperature 2 Degrees Celsius 30 Degrees Celsius Storage Environment Temperature 2 Degrees Celsius 42 Degrees Celsius Storage Environment Temperature 36 Degrees Fahrenheit 86 Degrees Fahrenheit Storage Environment Temperature 36 Degrees Fahrenheit 108 Degrees Fahrenheit
Regulatory Flags# DUNS number 355470923 Device count 30 DM exempt false Premarket exempt true HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label true 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 00050428344095 CVS Health WOONSOCKET PRESCRIPTION CENTER, INCORPORATED KGX 2026-10-16 20665973032423 Dukal Dukal LLC KGX 2026-10-14 20665973032430 Dukal Dukal LLC KGX 2026-10-14 00050428142677 CVS Health WOONSOCKET PRESCRIPTION CENTER, INCORPORATED KGX 2026-10-10 00050428143124 CVS Health WOONSOCKET PRESCRIPTION CENTER, INCORPORATED KGX 2026-10-10 00050428340523 CVS Health WOONSOCKET PRESCRIPTION CENTER, INCORPORATED KGX 2026-10-10 00050428340936 CVS Health WOONSOCKET PRESCRIPTION CENTER, INCORPORATED KGX 2026-10-10 00050428341308 CVS Health WOONSOCKET PRESCRIPTION CENTER, INCORPORATED KGX 2026-10-10 00050428342053 CVS Health WOONSOCKET PRESCRIPTION CENTER, INCORPORATED KGX 2026-10-10 00050428342121 CVS Health WOONSOCKET PRESCRIPTION CENTER, INCORPORATED KGX 2026-10-10 00050428342602 CVS Health WOONSOCKET PRESCRIPTION CENTER, INCORPORATED KGX 2026-10-10 00050428346396 CVS Health WOONSOCKET PRESCRIPTION CENTER, INCORPORATED KGX 2026-10-10 00050428347133 CVS Health WOONSOCKET PRESCRIPTION CENTER, INCORPORATED KGX 2026-10-10 00389152744957 Adhesive Sleeve, 10 Pack, Tandem Mobi Tandem Diabetes Care, Inc. KGX 2026-10-07 00389152745459 Adhesive Sleeve, 2 Pack, Tandem Mobi Tandem Diabetes Care, Inc. KGX 2026-10-07 00848253002224 InHealth Technologies; Blom-Singer Freudenberg Medical, LLC BYD 2026-10-06 00848253002231 InHealth Technologies; Blom-Singer Freudenberg Medical, LLC BYD 2026-10-06 00848253002248 InHealth Technologies; Blom-Singer Freudenberg Medical, LLC BYD 2026-10-06 00848253002279 InHealth Technologies; Blom-Singer Freudenberg Medical, LLC BYD 2026-10-06 00848253002286 InHealth Technologies; Blom-Singer Freudenberg Medical, LLC BYD 2026-10-06 00848253002309 InHealth Technologies; Blom-Singer Freudenberg Medical, LLC BYD 2026-10-06 00848253002316 InHealth Technologies; Blom-Singer Freudenberg Medical, LLC BYD 2026-10-06 00848253002323 InHealth Technologies; Blom-Singer Freudenberg Medical, LLC BYD 2026-10-06 00197998029844 Solventum™ Micropore™ Solventum Germany GmbH KGX 2026-10-05 00311917088556 Walgreens WALGREEN CO. KGX 2026-09-30 08859922800036 Equate WAL-MART STORES, INC. KGX 2026-09-30 08859922800043 Equate WAL-MART STORES, INC. KGX 2026-09-30 08859922800050 Equate WAL-MART STORES, INC. KGX 2026-09-30 08859922800067 Equate WAL-MART STORES, INC. KGX 2026-09-30 00850087488877 Ceeport CEEPORT INC. KGX 2026-09-29
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