Identity
- Trade Name
- HomeChoice PRO APD System FDA UDI
- Generic Name
- Peritoneal dialysis system FDA UDI
- Device Name
- The HomeChoice PRO Automated Personal Cycler is intended for automatic control of dialysate solution exchanges in the treatment of pediatric and adult renal failure patients undergoing peritoneal dialysis. FDA UDI
- Model / Reference
- 5C8310 FDA UDI
- Description
- The HomeChoice PRO Automated Personal Cycler is intended for automatic control of dialysate solution exchanges in the treatment of pediatric and adult renal failure patients undergoing peritoneal dialysis. FDA UDI
Identifiers
- Catalog Number
- 5C8310 FDA UDI
- Primary DI / UDI-DI
- 00085412079165 FDA UDI
- FDA Product Code
- FKX FDA UDI
- GMDN Term
- Peritoneal dialysis system 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Peritoneal dialysis system
HomeChoice PRO APD System by Baxter International Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 ec3d0cf8-9578-4912-8fca-87b3b356e101 36 fields · synced May 30, 2026