BZE

Product Code: BZE


Products Classified as BZE

67Heater, Breathing System W/wo Controller (not Humidifier Or NebulizerBreathing System Heater.

Total Product Life Cycle (TPLC) Devices

67Heater, Breathing System W/wo Controller (not Humidifier Or NebulizerBreathing System Heater.

FDA Consensus Standards

Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer [36712]21 CFR §868.5270 🔎
Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer [36713]21 CFR §868.5270 🔎
Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer [36710]21 CFR §868.5270 🔎
Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer [36711]21 CFR §868.5270 🔎
Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer [38929]21 CFR §868.5270 🔎

Pre-market Notifications for BZE

K201418Sunset Heated CPAP TubeSunset Healthcare Solutions, Inc.
K173280Neonatal ConchaSmart Breathing CircuitsTeleflex Medical, Inc
K170378AirLife Adult Heated Wire BiPAP/NIV CircuitVyaire Medical
K162553AirSpiral Heated Breathing TubeFISHER & PAYKEL HEALTHCARE
K160540FLEXICARE NEONATAL HEATED WIRE BREATHING SYSTEMFLEXICARE MEDICAL LIMITED
K153234AirLife Adult Heated Wire CircuitCAREFUSION INC
K151959AirLife Infant Single Limb Heated Wire CircuitCAREFUSION INC
K151461Hybernite RTPLASTIFLEX GROUP NV
K151303AirLife Infant Heated Wire CircuitCAREFUSION
K150900Flexicare Heated Wire Breathing SystemsFLEXICARE MEDICAL LTD.
K140424RESPIRONICS REUSABLE HEATED TUBINGRESPIRONICS, INC.
K122432ADULT EVAQUA 2' DUAL HEATED BREATHING CIRCUITSFISHER & PAYKEL HEALTHCARE, LTD.
K110398RESPIRONICS DISPOSABLE HEATED WIRE CIRCUITSRESPIRONICS, INC.
K103767DUAL HEATED INFANT VREATHING CIROUITSFISHER & PAYKEL HEALTHCARE LTD.
K100104HYBERNITE RAINOUT CONTROL SYSTEMPLASTIFLEX GROUP NV

Global Unique Device Identification Database

40606959026115HEATER, BREATHING SYSTEM W/WO CONTROLLER (NOT HUMIDIFIER OR NEBULIZER
30606959026101HEATER, BREATHING SYSTEM W/WO CONTROLLER (NOT HUMIDIFIER OR NEBULIZER
40606959026092HEATER, BREATHING SYSTEM W/WO CONTROLLER (NOT HUMIDIFIER OR NEBULIZER
40606959026085HEATER, BREATHING SYSTEM W/WO CONTROLLER (NOT HUMIDIFIER OR NEBULIZER
10709078005463Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
10709078004497Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
10709078001144Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
10709078001137Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
10709078001120Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
10709078001113Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
10709078001106Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
10709078001090Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
00855573007686Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
00855573007648Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
00855573007617Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer

Maude Adverse Events

INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUITFISHER & PAYKEL HEALTHCARE LTD2020-03-20
TUBING HIGH FLOW NASAL CANNULA HEATERHAMILTON MEDICAL AG2020-03-17
INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUITFISHER & PAYKEL HEALTHCARE LTD2020-03-12
INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUITFISHER & PAYKEL HEALTHCARE LTD2020-03-11
ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUITFISHER & PAYKEL HEALTHCARE LIMITED2020-03-04
ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUITFISHER & PAYKEL HEALTHCARE LIMITED2020-03-04
INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUITFISHER & PAYKEL HEALTHCARE LIMITED2020-03-02
HUDSON THERMAGARD NEBULIZER HEATERTELEFLEX MEDICAL2020-03-02
INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUITFISHER & PAYKEL HEALTHCARE LIMITED2020-03-01
TUBING ASSEMBLY INFANT RESP O2 30/CSVYAIRE MEDICAL.2020-02-28
HUDSON AQUATHERM HEATER 091TELEFLEX MEDICAL2020-02-28
INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUITFISHER & PAYKEL HEALTHCARE LTD2020-02-28
ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUITFISHER & PAYKEL HEALTHCARE LIMITED2020-02-28
INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUITFISHER & PAYKEL HEALTHCARE LTD2020-02-27
INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUITFISHER & PAYKEL HEALTHCARE LTD2020-02-27
ADULT VENTILATOR DUAL HEATED CIRCUIT KITFISHER & PAYKEL HEALTHCARE LTD2020-02-26
ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUITFISHER & PAYKEL HEALTHCARE LTD2020-02-26
INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUITFISHER & PAYKEL HEALTHCARE LTD2020-02-25
INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUITFISHER & PAYKEL HEALTHCARE LTD2020-02-25
ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUITFISHER & PAYKEL HEALTHCARE LIMITED2020-02-20
ADULT VENTILATOR DUAL HEATED CIRCUIT KITFISHER & PAYKEL HEALTHCARE LTD2020-02-20
INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUITFISHER & PAYKEL HEALTHCARE LTD2020-02-20
INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUITFISHER & PAYKEL HEALTHCARE LTD2020-02-19
INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUITFISHER & PAYKEL HEALTHCARE LTD2020-02-18
INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUITFISHER & PAYKEL HEALTHCARE LTD2020-02-18
INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUITFISHER & PAYKEL HEALTHCARE LTD2020-02-18
INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUITFISHER & PAYKEL HEALTHCARE LTD2020-02-12
INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUITFISHER & PAYKEL HEALTHCARE LTD2020-02-12
INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUITFISHER & PAYKEL HEALTHCARE LTD2020-02-04
INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUITFISHER & PAYKEL HEALTHCARE LTD2020-01-23
ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUITFISHER & PAYKEL HEALTHCARE LTD2020-01-22
ADULT VENTILATOR DUAL HEATED CIRCUIT KITFISHER & PAYKEL HEALTHCARE LTD2020-01-20
INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUITFISHER & PAYKEL HEALTHCARE LTD2020-01-16
HEATED BREATHING TUBEFISHER & PAYKEL HEALTHCARE LTD2020-01-16
INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUITFISHER & PAYKEL HEALTHCARE LTD2020-01-15
HUDSON AQUATHERM III,ELECTRONIC HEATERTELEFLEX MEDICAL2020-01-14
ADULT VENTILATOR DUAL HEATED CIRCUIT KITFISHER & PAYKEL HEALTHCARE LTD2020-01-12
ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUITFISHER & PAYKEL HEALTHCARE LIMITED2020-01-12
INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUITFISHER & PAYKEL HEALTHCARE LTD2020-01-11
INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUITFISHER & PAYKEL HEALTHCARE LTD2020-01-09
INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUITFISHER & PAYKEL HEALTHCARE LIMITED2020-01-09
INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUITFISHER & PAYKEL HEALTHCARE LIMITED2020-01-08
HUDSON THERMAGARD NEBULIZER HEATERTELEFLEX MEDICAL2020-01-06
HUDSON THERMAGARD NEBULIZER HEATERTELEFLEX MEDICAL2020-01-06
INFANT LOW FLOW BREATHING CIRCUITFISHER & PAYKEL HEALTHCARE LTD2020-01-02
INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUITFISHER & PAYKEL HEALTHCARE LTD2019-12-31
INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUITFISHER & PAYKEL HEALTHCARE LTD2019-12-29
INFANT BIAS FLOW BREATHING CIRCUITFISHER & PAYKEL HEALTHCARE LIMITED2019-12-26
INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUITFISHER & PAYKEL HEALTHCARE LTD2019-12-26
INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUITFISHER & PAYKEL HEALTHCARE LTD2019-12-26
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.