Home GUDID 00848530090081 Nebulizer
Primary DI 00848530090081
Brand Nebulizer
Company SUNSET HEALTHCARE SOLUTIONS, INC.
Model RES094
Device description Large Volume Non-Prefilled Nebulizer
Published 2024-06-24
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC false
Sterile false
Single use true Product Codes# Code, Name table Code Name CAF Nebulizer (Direct Patient Interface)
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class CAF Nebulizer (Direct Patient Interface) Anesthesiology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00848530090081 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00848530090081 00848530090081 848530090081 0848530090081
GMDN Terms# Term, Definition table Term Definition Benchtop nebulizer, non-heated An assembly of devices intended to be used in the home and clinical settings to generate non-heated aerosolized medication/fluids for inhalation by a patient, typically to treat/manage a respiratory disorder [e.g., chronic obstructive pulmonary disease (COPD), cystic fibrosis (CF)]. It may be a benchtop or trolley-mounted assembly and includes an electrically-powered generator (ultrasonic and/or compressor jet type), a reservoir, and a nebulizing chamber where the nebulization of the medicine usually occurs. Disposable devices (e.g., tubing, mask, mouthpiece) are attached to the device for inhalation.
Regulatory Flags# DUNS number 141668116 Device count 1 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 false Expiration date on label false 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 00604351673106 MC 300 Reusable Nebulizer Monaghan Medical Corporation CAF 2026-05-26 44710810080584 N/A GALEMED CORPORATION CAF 2026-03-05 44710810082120 N/A GALEMED CORPORATION CAF 2026-03-05 44710810082960 N/A GALEMED CORPORATION CAF 2026-03-05 44710810084988 N/A GALEMED CORPORATION CAF 2026-03-05 44710810085060 N/A GALEMED CORPORATION CAF 2026-03-05 44710810085947 N/A GALEMED CORPORATION CAF 2026-03-05 44710810086005 N/A GALEMED CORPORATION CAF 2026-03-05 44710810088283 N/A GALEMED CORPORATION CAF 2026-03-05 44710810088962 N/A GALEMED CORPORATION CAF 2026-03-05 44710810089488 N/A GALEMED CORPORATION CAF 2026-03-05 44710810110847 N/A GALEMED CORPORATION CAF 2026-03-05 44710810112650 N/A GALEMED CORPORATION CAF 2026-03-05 20889483230005 VixOne™ SUNMED, LLC CAF 2026-02-11 00199874417059 Airpulse AIRPULSE LTD CAF 2026-02-03 00810178886371 Vive Breathe VIVE HEALTH LLC CAF 2026-02-02 00810178884049 Vive Breathe VIVE HEALTH LLC CAF 2026-01-30 00810178884681 Vive Breathe VIVE HEALTH LLC CAF 2026-01-30 00810178886814 Vive Breathe VIVE HEALTH LLC CAF 2026-01-30 04719873130153 AdheResp HCMED INNOVATIONS CO., LTD. CAF 2026-01-29 04719873130207 Aerogen® Go HCMED INNOVATIONS CO., LTD. CAF 2026-01-28 04719873130214 Aerogen® Go HCMED INNOVATIONS CO., LTD. CAF 2026-01-28 04719873130351 Aerogen® Go HCMED INNOVATIONS CO., LTD. CAF 2026-01-28 00848530107932 Nebulizer and Compressor SUNSET HEALTHCARE SOLUTIONS, INC. CAF 2026-01-26 04719873131228 Aerogen® Go HCMED INNOVATIONS CO., LTD. CAF 2026-01-22 04719873131235 Pulmogine® HCMED INNOVATIONS CO., LTD. CAF 2026-01-22 46923980103689 N/A GaleMed Xiamen Co., Ltd. CAF 2026-01-22 46923980105430 N/A GaleMed Xiamen Co., Ltd. CAF 2026-01-22 46923980105461 N/A GaleMed Xiamen Co., Ltd. CAF 2026-01-22 46923980105485 N/A GaleMed Xiamen Co., Ltd. CAF 2026-01-22
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