Search Results
Found 2 results
510(k) Data Aggregation
K Number
K153234Device Name
AirLife Adult Heated Wire Circuit
Manufacturer
CAREFUSION INC
Date Cleared
2016-07-07
(241 days)
Product Code
BZE
Regulation Number
868.5270Why did this record match?
Applicant Name (Manufacturer) :
CAREFUSION INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The AirLife Adult Heated Wire Circuit is intended to warm breathing gases before they enter a patient's airway. The AirLife Adult Heated Wire Circuit is used with the adult patient population that requires mechanical ventilation, positive pressure breathing or general medical gases. The product is single use device, non-sterile and used in professional healthcare environments and intra-hospital transport environments under a doctor's supervision and by skilled clinicians. The AirLife Adult Heated Wire Circuit is compatible to the Fisher & Paykel MR850 humidifier.
Device Description
The heated breathing circuit is intended to deliver and warm breathing gases before they enter the patient's airway. It is provided non sterile for single patient use. The heated breathing circuit is used with Fisher and Paykel heated humidifier.
Ask a Question
K Number
K151959Device Name
AirLife Infant Single Limb Heated Wire Circuit
Manufacturer
CAREFUSION INC
Date Cleared
2016-01-20
(188 days)
Product Code
BZE
Regulation Number
868.5270Why did this record match?
Applicant Name (Manufacturer) :
CAREFUSION INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The heated breathing circuit is intended to deliver and warm breathing gases before they enter the patient's airway. The heated breathing circuit is used with Fisher and Paykel heated humidifier MR850. The AirLife Infant Single Limb Heated Wire Circuit is intended for use with pediatic population, specifically the neonate (birth to 1 month of age) and infant (greater than 1 month to 2 years of age) pediative subgroups. The product is single use device, non-sterile and used in professional healthcare environments and intra-hospital transport environments under a supervision and by skilled clinicians.
Device Description
The heated breathing circuit is intended to deliver and warm breathing gases before they enter the patient's airway. It is provided non sterile for single patient use. The heated breathing circuit is used with Fisher and Paykel heated humidifier MR850.
Ask a Question
Page 1 of 1