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.

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• 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