ClearanceBrief
Panels › Anesthesiology › Product code BZE · Class 2

Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer

Regulation 868.5270

2510(k)s in 12 months (46 all time)
0recalls in 12 months (7 all time)
7recalls that name a 510(k)
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Top companies in BZE

DateFirm and productCodeLinked 510(k)
May 9, 2025Vyaire Medical
Brand Name: AirLife Product Name: AirLife Infant Heated Wire Circuit Model/Catalog Number: AH265 Software Version: N/A Product Description: AirLife Infant Heated Wire Circuit Kit Dual-limb, Dual-heat,
Open, Classified
BZEK151303
May 9, 2025Vyaire Medical
Brand Name: AirLife Product Name: AirLife Infant Heated Wire Circuit Model/Catalog Number: AH165 Software Version: N/A Product Description: AirLife Infant Heated Wire Circuit dual-limb, dual-heat, hig
Open, Classified
BZEK151303
Jul 15, 2019Teleflex Medical
Teleflex HUDSON RDI NEONATAL ConchaSmart Breathing Circuit with Dual Heated Limb and ConchaSmart Column: a) REF 870-07KIT b) REF 870-09KIT Product Usage: The Neonatal ConchaSmart breathing cir
Terminated
BZEK173280
Sep 23, 2014Carefusion 2200 Inc
CareFusion AirLife Heated Infant Breathing Circuit Product Usage: Respiratory breathing circuits are used with a ventilator when mechanical ventilation is administered to a patient.
Terminated
BZEK915226
Jun 29, 2012Carefusion 2200 Inc
AirLife Isothermal Breathing Circuit Accessory - Infant Patient Y Connector; an Rx device for single patient use; 30 connectors per box; CareFusion, 22745 Savi Ranch Parkway, Yorba Linda, CA 92887 USA
Terminated
BZEK915226
Jun 29, 2012Carefusion 2200 Inc
AirLife Isothermal Breathing Circuit, Infant Respiratory Circuit, Non-Heated; an Rx device for single patient use; CareFusion, 22745 Savi Ranch Parkway, Yorba Linda, CA 92887 USA, Made in Mexico Resp
Terminated
BZEK915226
Jun 29, 2012Carefusion 2200 Inc
AirLife Isothermal Breathing Circuit, Infant Respiratory Circuit, Heated; an Rx device for single patient use; CareFusion, 22745 Savi Ranch Parkway, Yorba Linda, CA 92887 USA, Made in Mexico Respirat
Terminated
BZEK915226

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