Identity
- Trade Name
- Liberty® FDA UDI
- Generic Name
- Peritoneal dialysis system tubing set FDA UDI
- Device Name
- Liberty® Cycler Set with Dual stay.safe® PIN Connector FDA UDI
- Model / Reference
- 050-87212 FDA UDI
- Description
- Liberty® Cycler Set with Dual stay.safe® PIN Connector FDA UDI
Identifiers
- Catalog Number
- 050-87212 FDA UDI
- Primary DI / UDI-DI
- 00840861100736 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
Liberty® by Fresenius Medical Care Holdings, 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
- Cycler Drainage Bag — BAXTER INTERNATIONAL INC. · Class II
- Manifold Set — BAXTER INTERNATIONAL INC. · Class II
- LOW RECIRCULATION VOLUME APD SET — BAXTER INTERNATIONAL INC. · Class II
- UltraSet CAPD Disposable Disconnect Y-Set — BAXTER INTERNATIONAL INC. · Class II
- HOMECHOICE APD SET — BAXTER INTERNATIONAL INC. · Class II
- MiniCap — Baxter Healthcare Corp · Class II
- Extension Set — BAXTER INTERNATIONAL INC. · Class II
Cleared under the same submission
K043363 also covers:
K173718 also covers:
- Liberty® — Fresenius Medical Care Holdings, Inc.
- Liberty® — Fresenius Medical Care Holdings, Inc.
- stay•safe® Handi-tool — Fresenius Medical Care Holdings, Inc.
- stay•safe® organizer — Fresenius Medical Care Holdings, Inc.
- stay•safe® organizer holder — Fresenius Medical Care Holdings, Inc.
- Liberty — Fresenius Medical Care Renal Therapies Group, LLC
- Liberty — Fresenius Medical Care Renal Therapies Group, LLC
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
- Fresenius Medical Care Holdings, Inc.
Sources (1)
- FDA UDI eebbbdd4-55fe-4101-9aa4-70cbe1d4f3c5 36 fields · synced May 30, 2026