Identity
- Trade Name
- Amia Automated PD Set with Cassette FDA UDI
- Generic Name
- Peritoneal dialysis system tubing set FDA UDI
- Device Name
- Amia Automated PD Set with Cassette is used to deliver and drain solution to and from the peritoneal cavity during treatment. FDA UDI
- Model / Reference
- 5C5479 FDA UDI
- Description
- Amia Automated PD Set with Cassette is used to deliver and drain solution to and from the peritoneal cavity during treatment. FDA UDI
Identifiers
- Catalog Number
- 5C5479 FDA UDI
- Primary DI / UDI-DI
- 00085412153186 FDA UDI
- FDA Product Code
- FKX FDA UDI
- GMDN Term
- Peritoneal dialysis system tubing set 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
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Peritoneal dialysis system tubing set
Amia Automated PD Set with Cassette 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 9d686438-815e-48d4-8c84-818e833f2ff1 35 fields · synced Jun 6, 2026