Identity
- Trade Name
- Extension Set with EASY-LOCK Connector 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 patient line of the Baxter Automated PD Disposable Sets. FDA UDI
- Model / Reference
- 5C4480C FDA UDI
- Description
- This device is indicated for use in the treatment of patients with renal failure to provide extended length to the patient line of the Baxter Automated PD Disposable Sets. FDA UDI
Identifiers
- Catalog Number
- 5C4480C FDA UDI
- Primary DI / UDI-DI
- 00085412087382 FDA UDI
- 510(k) Number
- K925403 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
Dimensions & Sizes
- Size
- Length — 12 Feet FDA UDI
Category: Peritoneal dialysis system tubing set
Extension Set with EASY-LOCK Connector 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
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Baxter International Inc.
Sources (1)
- FDA UDI 5e43b677-e947-460b-ba0e-039cc37d2f12 38 fields · synced Jun 8, 2026