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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)
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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the Original HDE to get an up-to-date view of this device.
 
Trade NameSpiration Valve System
Classification Nameone-way air-leak valve
Generic Nameone-way air-leak valve
Applicant
Gyrus Acmi, Inc.
6675 185th ave. ne
redmond, WA 98052
HDE NumberH060002
Supplement NumberS015
Date Received07/18/2024
Decision Date08/20/2024
Product Code
OAZ[ Registered Establishments with OAZ ]
Advisory Committee Anesthesiology
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
The addition of a supplier for microbial monitoring nutrient media plates, nutrient media incubation and plate counting, the addition of a supplier for an active air sampler, and minor updates to the olympus redmond environmental monitoring, controlled environment work instruction (wi).
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