Identity
- Trade Name
- Smart Anemia Manager (SAM) FDA UDI
- Generic Name
- Nephrology information system application software FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860005737512 FDA UDI
- FDA Product Code
- MQS FDA UDI
- GMDN Term
- Nephrology information system application software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5820 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Nephrology information system application software
Smart Anemia Manager (SAM) by Dosis, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Nephrology information system application software.
- Sharesource Connectivity Platform — BAXTER INTERNATIONAL INC. · Class II
- PhySoft AMS — PHYSICIAN SOFTWARE SYSTEMS, LLC · Class II
- Sharesource Connectivity Platform — BAXTER INTERNATIONAL INC. · Class II
- Sharesource — Baxter Healthcare Corp · Class II
- Sharesource — Baxter Healthcare Corp · Class II
- Sharesource Connectivity Platform — BAXTER INTERNATIONAL INC. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Dosis, Inc.
Sources (1)
- FDA UDI 9ee56ff8-8e67-4e7a-813e-687bea3ed321 33 fields · synced May 30, 2026