Home GUDID 04816415501362 OXYGEN MASK Single Use Size 4
Primary DI 04816415501362
Brand OXYGEN MASK Single Use Size 4
Company ASSOMEDIKA, OOO
Model N/A
Device description A flexible, form-shaped device designed to be placed over the nose and mouth to deliver a near-precise mixture of air and oxygen (O2) to a patient's airway without the use of a gas mixer. The device typically includes a variety of exchangeable inserts (the venturi) that allow air entrainment in controlled amounts to provide the desired O2 concentration. It is connected to an O2 source with tubing and includes headstraps for stabilization. Adaptors are typically included for connection to a humidification source. This is a single-use device.
Published 2026-05-26
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC true
Sterile true
Single use true
Product Codes# Code, Name table Code Name BYG Mask, Oxygen
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class BYG Mask, Oxygen Anesthesiology 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 04816415501362 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 04816415501362 04816415501362 4816415501362
GMDN Terms# Term, Definition table Term Definition Venturi oxygen face mask A flexible, form-shaped device designed to be placed over the nose and mouth to deliver a near-precise mixture of air and oxygen (O2) to a patient's airway without the use of a gas mixer. The device typically includes a variety of exchangeable inserts (the venturi) that allow air entrainment in controlled amounts to provide the desired O2 concentration. It is connected to an O2 source with tubing and includes headstraps for stabilization. Adaptors are typically included for connection to a humidification source. This is a single-use device.
Regulatory Flags# DUNS number 683522555 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 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 00840118621137 Endure Industries ENDURE INDUSTRIES BYG 2026-08-17 00840118621144 Endure Industries ENDURE INDUSTRIES BYG 2026-08-14 04719874950675 Create Biotech CREATE BIOTECH CO., LTD. BYG 2026-07-21 04719874950972 Create Biotech CREATE BIOTECH CO., LTD. BYG 2026-07-21 04719874951153 Create Biotech CREATE BIOTECH CO., LTD. BYG 2026-07-21 04719874951160 Create Biotech CREATE BIOTECH CO., LTD. BYG 2026-07-21 04719874951177 Create Biotech CREATE BIOTECH CO., LTD. BYG 2026-07-21 04719874951184 Create Biotech CREATE BIOTECH CO., LTD. BYG 2026-07-21 04719874955793 Create Biotech CREATE BIOTECH CO., LTD. BYG 2026-07-21 04719874955809 Create Biotech CREATE BIOTECH CO., LTD. BYG 2026-07-21 04719874955816 Create Biotech CREATE BIOTECH CO., LTD. BYG 2026-07-21 04719874956264 Create Biotech CREATE BIOTECH CO., LTD. BYG 2026-07-21 04719874956271 Create Biotech CREATE BIOTECH CO., LTD. BYG 2026-07-21 04719874956288 Create Biotech CREATE BIOTECH CO., LTD. BYG 2026-07-21 04719874956295 Create Biotech CREATE BIOTECH CO., LTD. BYG 2026-07-21 04719874956301 Create Biotech CREATE BIOTECH CO., LTD. BYG 2026-07-21 04719874956318 Create Biotech CREATE BIOTECH CO., LTD. BYG 2026-07-21 00607411919039 Salter Labs® High Concentration partial rebreather SALTER LABS BYG 2026-06-10 00607411919336 Salter Labs® Percent-O2-Lock® Mask SALTER LABS BYG 2026-06-10 00607411919008 Salter Labs® Adult Comfort Face Tent SALTER LABS BYG 2026-06-09 00607411919053 Salter Labs® Oxygen Mask SALTER LABS BYG 2026-06-09 00607411919060 Salter Labs® Oxygen Mask SALTER LABS BYG 2026-06-09 04816415501379 LARYNGEAL MASK Single Use Size 2 ASSOMEDIKA, OOO BYG 2026-05-27 04816415501386 LARYNGEAL MASK Single Use Size 3 ASSOMEDIKA, OOO BYG 2026-05-27 04816415501393 LARYNGEAL MASK Single Use Size 5 ASSOMEDIKA, OOO BYG 2026-05-27 08697645018129 ENDURE INDUSTRIES ENDURE INDUSTRIES BYG 2026-04-17 08697645018136 ENDURE INDUSTRIES ENDURE INDUSTRIES BYG 2026-04-17 08697645018143 ENDURE INDUSTRIES ENDURE INDUSTRIES BYG 2026-04-17 00848530108717 Nasal CPAP Mask Sunset Healthcare Solutions, Inc. BYG 2026-04-07 00848530108724 Nasal CPAP Mask Sunset Healthcare Solutions, Inc. BYG 2026-04-07