Home GUDID 10607411000338 n/a
Primary DI 10607411000338
Brand n/a
Company SALTER LABS
Model 8057-0
Catalog number 8057-0
Device description The Percent-O2-Lock Assembly
Published 2016-11-30
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 BYF MASK, OXYGEN, LOW CONCENTRATION, VENTURI
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class BYF Mask, Oxygen, Low Concentration, Venturi Anesthesiology 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10607411000338 Package GS1 50 In Commercial Distribution 00607411000331 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 10607411000338 10607411000338 00607411000331 00607411000331 607411000331 0607411000331
GMDN Terms# Term, Definition table Term Definition Non-rebreathing oxygen face mask A non-sterile, flexible, form-shaped device designed to be placed over the nose and mouth to deliver air of high oxygen (O2) concentration to a patient's airway. It typically includes two unidirectional valves, one that closes during inspiration to prevent room air mixing with oxygen in a reservoir bag, and one that closes during exhalation to prevent exhaled respiratory gases from entering the reservoir bag. It is made of soft, flexible polymers designed to create an airtight seal against the patient's face. It may include tubing, and various valves and connectors, however other respiratory equipment (e.g., nebulizer, humidifier, CPAP device) is not included. This is a single-use device.
Regulatory Flags# DUNS number 022721133 Device count 1 DM exempt false Premarket exempt true HCT/P false Kit true 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 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 00851232007202 OXYJET VENTURI DEVICE WITH TUBING D R BURTON HEALTHCARE, LLC BYF 2026-04-28 10889483569436 AirLife™ AIRLIFE BYF 2025-02-19 30889483569430 AirLife™ Sunmed Group Holdings, LLC BYF 2025-02-19 00848530099114 Aerosol & Nebs SUNSET HEALTHCARE SOLUTIONS, INC. BYF 2024-08-07 00848530089955 Tracheostomy Oxygen Maskc SUNSET HEALTHCARE SOLUTIONS, INC. BYF 2024-06-27 00848530096250 Aerosol & Nebs SUNSET HEALTHCARE SOLUTIONS, INC. BYF 2024-06-15 00848530092931 CPAP Kit SUNSET HEALTHCARE SOLUTIONS, INC. BYF 2024-06-08 00848530092948 CPAP Kit SUNSET HEALTHCARE SOLUTIONS, INC. BYF 2024-06-08 00848530092955 CPAP Kit SUNSET HEALTHCARE SOLUTIONS, INC. BYF 2024-06-08 00848530092962 CPAP Kit SUNSET HEALTHCARE SOLUTIONS, INC. BYF 2024-06-08 00848530092979 CPAP Kit SUNSET HEALTHCARE SOLUTIONS, INC. BYF 2024-06-08 00848530092986 CPAP Kit SUNSET HEALTHCARE SOLUTIONS, INC. BYF 2024-06-08 00848530092993 CPAP Kit SUNSET HEALTHCARE SOLUTIONS, INC. BYF 2024-06-08 00848530093006 CPAP Kit SUNSET HEALTHCARE SOLUTIONS, INC. BYF 2024-06-08 00848530093013 CPAP Kit SUNSET HEALTHCARE SOLUTIONS, INC. BYF 2024-06-08 00848530097066 CPAP Mask SUNSET HEALTHCARE SOLUTIONS, INC. BYF 2024-06-07 00628725095554 Pediatric Vari-vent mask Canadian Hospital Specialties Limited BYF 2024-05-16 50628725095559 Pediatric Vari-vent mask Canadian Hospital Specialties Limited BYF 2024-05-16 14026704923530 RUSCH TELEFLEX INCORPORATED BYF 2024-04-26 24026704923537 RUSCH TELEFLEX INCORPORATED BYF 2024-04-26 05030267166060 VENTURI VALVE 24% OXYGEN, BLUE Intersurgical Incorporated BYF 2024-04-04 05030267166138 VENTURI VALVE 28% OXYGEN, WHITE Intersurgical Incorporated BYF 2024-04-04 05030267166169 VENTURI VALVE 35% OXYGEN, YELLOW Intersurgical Incorporated BYF 2024-04-04 05030267166190 VENTURI VALVE 40% OXYGEN, RED Intersurgical Incorporated BYF 2024-04-04 05030267166220 VENTURI VALVE 60% OXYGEN, GREEN Intersurgical Incorporated BYF 2024-04-04 05030267166251 VENTURI VALVE 50% OXYGEN, PINK Intersurgical Incorporated BYF 2024-04-04 05030267166282 VENTURI VALVE 31% OXYGEN, ORANGE Intersurgical Incorporated BYF 2024-04-04 05030267166077 VENTURI VALVE 24% OXYGEN, BLUE Intersurgical Incorporated BYF 2024-04-04 05030267166145 VENTURI VALVE 28% OXYGEN, WHITE Intersurgical Incorporated BYF 2024-04-04 05030267166176 VENTURI VALVE 35% OXYGEN, YELLOW Intersurgical Incorporated BYF 2024-04-04
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