Identity
- Trade Name
- Manifold Set FDA UDI
- Generic Name
- Peritoneal dialysis system tubing set FDA UDI
- Device Name
- This set is designed for infusion of peritoneal dialysis solution. This set consists of a white luer lock connector (with blue pull ring cap) which is intended to connect to a supply line of an APD Set with Cassette and 5 blue luer lock connectors (with clear pull ring caps) which are intended to connect to solution bags (with Luers). Manifold Set 5-Prong FDA UDI
- Model / Reference
- L5C4446 FDA UDI
- Description
- This set is designed for infusion of peritoneal dialysis solution. This set consists of a white luer lock connector (with blue pull ring cap) which is intended to connect to a supply line of an APD Set with Cassette and 5 blue luer lock connectors (with clear pull ring caps) which are intended to connect to solution bags (with Luers). Manifold Set 5-Prong FDA UDI
Identifiers
- Catalog Number
- L5C4446 FDA UDI
- Primary DI / UDI-DI
- 00085412090092 FDA UDI
- 510(k) Number
- K791899 FDA UDI
- FDA Product Code
- KDJ 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
Manifold Set by Baxter International Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Peritoneal dialysis system tubing set.
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- MiniCap — Baxter Healthcare Corp · Class II
- VersiPD — Fresenius Medical Care Holdings, Inc. · Class II
- Liberty® PDx — Fresenius Medical Care Holdings, Inc. · Class II
Cleared under the same submission
K791899 also covers:
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 17eea6fa-208a-4d1b-b37c-8892cd38268e 37 fields · synced Jun 1, 2026