PhySoft AMS

GUDID 00861858000303

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.

PHYSICIAN SOFTWARE SYSTEMS, LLC

Nephrology information system application software

• Primary Device ID: 00861858000303
• NIH Device Record Key: 7baa5dbe-9603-46af-8ebd-bcbdc83a31a2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PhySoft AMS
• Version Model Number: 1
• Company DUNS: 078367298
• Company Name: PHYSICIAN SOFTWARE SYSTEMS, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: (331) 213-2900
• Email: support@physoft.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00861858000303 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130579

FDA Product Code

• MQS: System, Hemodialysis, Access Recirculation Monitoring

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-26