FDA.reportPublic FDA data

PMA P850064S055

Device
LifePulse High Frequency Ventilator (HFV)
Applicant
Bunnell, Inc.
PMA number
P850064
Supplement
S055
Product code
LSZ
Decision date
2025-07-25
Classification
Anesthesiology
Generic name
VENTILATOR, HIGH FREQUENCY
Approval order statement
for a change to materials in the Patient Circuit based on their biocompatibility profile. The changes include: a change to circuit tubing material (no change to tubing type or dimensions), change in the anodization process of the heater cup, and replacing the adhesives used with medical grade adhesives.

Current openFDA PMA Record#

Device
LifePulse High Frequency Ventilator (HFV)
Applicant
Bunnell, Inc.
PMA number
P850064
Supplement
S055
Product code
LSZ
Generic name
VENTILATOR, HIGH FREQUENCY
Decision date
2025-07-25
Decision code
APPR
Date received
2024-10-02
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
for a change to materials in the Patient Circuit based on their biocompatibility profile. The changes include: a change to circuit tubing material (no change to tubing type or dimensions), change in the anodization process of the heater cup, and replacing the adhesives used with medical grade adhesives.