Home GUDID 44710810117464 N/A
Primary DI 44710810117464
Brand N/A
Company GALEMED CORPORATION
Model BC01
Catalog number AN0018
Device description Bubble PAP Valve
Published 2026-03-05
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use true Product Codes# Code, Name table Code Name BYE Attachment, Breathing, Positive End Expiratory Pressure
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class BYE Attachment, Breathing, Positive End Expiratory Pressure Anesthesiology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 44710810117464 Package GS1 12 In Commercial Distribution 04710810117466 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 44710810117464 44710810117464 04710810117466 04710810117466 4710810117466
GMDN Terms# Term, Definition table Term Definition CPAP/BPAP face mask, single-use A non-sterile, flexible, form-shaped device designed to be placed over a user's nose and mouth to interface with a continuous positive airway pressure (CPAP) or bi-level positive airway pressure (BPAP) unit to provide the respiratory tract with direct ambient air, or medical oxygen (O2) and air, at a higher pressure than ambient air for noninvasive positive pressure ventilation (NPPV). It is typically made of plastic/silicone materials that create an airtight seal around the nose and mouth. It is available in various designs and sizes and stabilized with a headstrap. This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.
Regulatory Flags# DUNS number 656854379 Device count 1 DM exempt false Premarket exempt false 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 true 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 00810094578534 Curaplex® BOUND TREE MEDICAL, LLC BYE 2025-08-06 00810094578008 Curaplex® BOUND TREE MEDICAL, LLC BYE 2025-07-09 00810094578015 Curaplex® BOUND TREE MEDICAL, LLC BYE 2025-07-09 00810094578022 Curaplex® BOUND TREE MEDICAL, LLC BYE 2025-07-09 00810094578039 Curaplex® BOUND TREE MEDICAL, LLC BYE 2025-07-09 00810094578046 Curaplex® BOUND TREE MEDICAL, LLC BYE 2025-07-09 00026072001479 EM Allied Medical, LLC BYE 2024-05-28 00810094574987 Curaplex BOUND TREE MEDICAL, LLC BYE 2023-02-28 00810094575007 Curaplex BOUND TREE MEDICAL, LLC BYE 2023-02-28 00810094574994 Curaplex BOUND TREE MEDICAL, LLC BYE 2023-02-28 00810094575014 Curaplex BOUND TREE MEDICAL, LLC BYE 2023-02-28 10884521831643 Shiley Covidien LP BYE 2023-02-18 10884521831636 Shiley Covidien LP BYE 2023-02-16 00810071637261 Curaplex BOUND TREE MEDICAL, LLC BYE 2022-12-30 00810071637278 Curaplex BOUND TREE MEDICAL, LLC BYE 2022-12-30 00709078013560 Bracket with Tube Guide WESTMED, INC. BYE 2021-10-15 00709078013546 WaterPAP Pole Clamp WESTMED, INC. BYE 2021-10-08 00709078013607 WaterPAP™ Starter Kit WESTMED, INC. BYE 2021-10-08 00709078013621 WaterPAP™ Pro Starter Kit WESTMED, INC. BYE 2021-10-08 00709078013195 WaterPAP WESTMED, INC. BYE 2021-08-31 10641043574041 Flow-Safe II+ BiLevel Disposable CPAP System MERCURY ENTERPRISES, INC. BYE 2021-01-14 10641043574058 Flow-Safe II+ BiLevel Disposable CPAP System MERCURY ENTERPRISES, INC. BYE 2021-01-14 10641043572443 Flow-Safe II Disposable CPAP System MERCURY ENTERPRISES, INC. BYE 2020-11-12 10641043572450 Flow-Safe II Disposable CPAP System MERCURY ENTERPRISES, INC. BYE 2020-11-12 10641043572467 Flow-Safe II Disposable CPAP System MERCURY ENTERPRISES, INC. BYE 2020-11-12 08498840012130 VYGON Vygon Corporation BYE 2020-03-12 15019315061066 Portex ICU MEDICAL, INC. BYE 2020-03-12 15019315061073 Portex ICU MEDICAL, INC. BYE 2020-03-12 15019315061080 Portex ICU MEDICAL, INC. BYE 2020-03-12 10190752133181 AirLife™ AIRLIFE BYE 2020-01-15