PHYSICIAN SOFTWARE SYSTEMS, LLC

Address:3333 Warrenville Rd Ste 200,Lisle,IL,60532,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

System, Hemodialysis, Access Recirculation Monitoring (MQS) (1)

Premarket Exempt

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PhySoft AMS - 00861858000303 Catalog Number :

Device Description : PhySoft AMS™ is a web application used to obtain, track and trend patient data p PhySoft AMS™ is a web application used to obtain, track and trend patient data pertaining to the management of anemia, and to provide a schedule of erythropoiesis stimulating agent (ESA) dosage recommendations to help achieve and maintain target hemoglobin levels in dialysis patients. PhySoft AMS™ is intended to help physicians, nurses, clinicians and anemia managers manage anemia in adult stage 5 chronic kidney disease (CKD) patients.

Device Class : 2

Duns Number: 078367298

Premarket Exempt : No

Product Code : MQS

Prescription Use : Yes

Device Count : 1

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