Home GUDID B005003940
AincA
Primary DI B005003940
Brand AincA
Company ANESTHESIA ASSOCIATES, INC.
Model 00-394
Catalog number 00-394
Device description "Valve, Bag-Tail Adjustable Pop-Off, 90° Type Single Hand, Evacuator w/Neg Relief, 3/8"" x 3/8"", Acrylic"
Published 2016-08-19
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx 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 B005003940 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Mechanical expiratory valve, reusable A non-sterile mechanical device intended to be used in a respiratory or anaesthesia breathing circuit to maintain a degree of positive pressure in a patient's airway at the end of expiration. Typically constructed of plastic/metal it has a valve that is actuated by a spring to provide expiratory airway resistance, and an adjustable knob (usually not graduated) that is typically set between 0 and 20 cmH20 pressure, but may be fully closed when controlled/assisted ventilation is applied. It is normally used with anaesthesia breathing systems, pulmonary resuscitators, or ventilators and is commonly known as a pop-off valve, relief valve, or spill valve. This is a reusable device.
Regulatory Flags# DUNS number 002065670 Device count 1 DM exempt true Premarket exempt true Lot or batch true No natural rubber latex true 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