Home GUDID 53660812032846 VYGON
Primary DI 53660812032846
Brand VYGON
Company VYGON
Model 5570.13
Catalog number 5570.13
Device description Boussignac / Vygon CPAP
Published 2016-09-14
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile true
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 33660812032842 Package GS1 5 In Commercial Distribution 53660812032846 Package GS1 12 In Commercial Distribution 03660812032841 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 33660812032842 33660812032842 53660812032846 53660812032846 03660812032841 03660812032841 3660812032841
GMDN Terms# Term, Definition table Term Definition In-line CPAP pressure generating chamber A sterile portable device intended to be integrated between a medical gas supply and a face mask/mouthpiece (not included) to assist noninvasive ventilation (i.e., without an artificial airway) using continuous positive airway pressure (CPAP) during spontaneous patient respiration in respiratory emergency situations and/or respiratory therapy settings. It is typically a small plastic unit intended to be used with a separate flowmeter and manometer to establish a gas pressure proportional to gas flow rate through turbulent gas flow in an internal chamber using accelerating micro-channels (a virtual valve); tubing may be included. This is a single-use device.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 5 Degrees Celsius 40 Degrees Celsius
Regulatory Flags# DUNS number 392994778 Device count 1 DM exempt true Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false 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 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