Smart Anemia Manager (SAM)

GUDID 00860005737512

SAM 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 (Hgb) levels in hemodialysis patients. The device is intended to help clinicians manage chronic anemia.

Dosis Inc.

Nephrology information system application software

• Primary Device ID: 00860005737512
• NIH Device Record Key: 9ee56ff8-8e67-4e7a-813e-687bea3ed321
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Smart Anemia Manager (SAM)
• Version Model Number: 1
• Company DUNS: 968916627
• Company Name: Dosis Inc.
• 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: false
• Manufacturing Date: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860005737512 [Primary]

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-03-17
• Device Publish Date: 2021-03-09