Identity
- Trade Name
- LOW RECIRCULATION VOLUME APD SET FDA UDI
- Generic Name
- Peritoneal dialysis system tubing set FDA UDI
- Device Name
- This Automated PD Set is compatible with Baxter Automated PD systems, Baxter PD Transfer Sets and Effluent Sample Bag. Use of the Clamp for Outlet Port is recommended. Low Recirculation Volume APD Set with Cassette (4-Prong Spike) FDA UDI
- Model / Reference
- 5C8302C FDA UDI
- Description
- This Automated PD Set is compatible with Baxter Automated PD systems, Baxter PD Transfer Sets and Effluent Sample Bag. Use of the Clamp for Outlet Port is recommended. Low Recirculation Volume APD Set with Cassette (4-Prong Spike) FDA UDI
Identifiers
- Catalog Number
- 5C8302C FDA UDI
- Primary DI / UDI-DI
- 00085412087405 FDA UDI
- 510(k) Number
- K012988 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
Low Recirculation Volume Apd Set 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 a9bc34cc-81e0-45aa-93e8-abe478216955 37 fields · synced Jun 1, 2026