Identity
- Trade Name
- Extension Set FDA UDI
- Generic Name
- Peritoneal dialysis system tubing set FDA UDI
- Device Name
- This device is indicated for use in the treatment of patients with renal failure to provide extended length to the drain line of the Baxter Automated PD Disposable Sets. FDA UDI
- Model / Reference
- 5C4464P FDA UDI
- Description
- This device is indicated for use in the treatment of patients with renal failure to provide extended length to the drain line of the Baxter Automated PD Disposable Sets. FDA UDI
Identifiers
- Catalog Number
- 5C4464P FDA UDI
- Primary DI / UDI-DI
- 00085412030555 FDA UDI
- 510(k) Number
- K833065 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
Dimensions & Sizes
- Size
- Length — 12 Feet FDA UDI
Category: Peritoneal dialysis system tubing set
Extension Set by Baxter International Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Peritoneal dialysis system tubing set.
- Easy-Lock — Baxter Healthcare Corp · Class II
- Safe-Lock® — Fresenius Medical Care Holdings, Inc. · Class II
- stay.safe® — Fresenius Medical Care Holdings, Inc. · Class II
- VersiPD — Fresenius Medical Care Holdings, Inc. · Class II
- Liberty® — Fresenius Medical Care Holdings, Inc. · Class II
- 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
K833065 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 c88c345a-da0a-46fb-915c-99a7586418fe 38 fields · synced Jun 1, 2026