Identity
- Trade Name
- Sharesource Connectivity Platform FDA UDI
- Generic Name
- Nephrology information system application software FDA UDI
- Device Name
- Sharesource is a web-based connectivity platform that allows authorized users, including nephrologists, clinicians, and nurses in the dialysis center, to remotely view and manage treatment information sent from the Amia APD System. FDA UDI
- Model / Reference
- 5C9400 FDA UDI
- Description
- Sharesource is a web-based connectivity platform that allows authorized users, including nephrologists, clinicians, and nurses in the dialysis center, to remotely view and manage treatment information sent from the Amia APD System. FDA UDI
Identifiers
- Catalog Number
- 5C9400 FDA UDI
- Primary DI / UDI-DI
- 45413765565692 FDA UDI
- 510(k) Number
- K151525 FDA UDI
- FDA Product Code
- FKX FDA UDI
- GMDN Term
- Nephrology information system application software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5630 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Nephrology information system application software
Sharesource Connectivity Platform by Baxter International Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Nephrology information system application software.
- PhySoft AMS — PHYSICIAN SOFTWARE SYSTEMS, LLC · Class II
- Sharesource — Baxter Healthcare Corp · Class II
- Sharesource — Baxter Healthcare Corp · Class II
- Smart Anemia Manager (SAM) — Dosis, Inc. · Class II
- Sharesource Connectivity Platform — BAXTER INTERNATIONAL INC. · Class II
- Sharesource Connectivity Platform — BAXTER INTERNATIONAL INC. · Class II
Cleared under the same submission
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 |
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Manufacturer
- Manufacturer
- Baxter International Inc.
Sources (1)
- FDA UDI 70e44d91-5587-430c-b961-56ea5c6acacc 36 fields · synced May 31, 2026