Identity
- Trade Name
- Sharesource Connectivity Platform FDA UDI
- Generic Name
- Nephrology information system application software FDA UDI
- Device Name
- Sharesourece 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
- Sharesourece 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
- 15413765565691 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
- Not 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
Sharesource Connectivity Platform by Baxter International Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 41ab0569-fcfb-4d3a-8e5e-3dfb19db58f5 37 fields · synced Jun 1, 2026