Identity
- Trade Name
- Easy-Lock FDA UDI
- Generic Name
- Peritoneal dialysis system tubing set FDA UDI
- Device Name
- This adapter consists of a spike connector, approx. 10.15 cm (4 inch) long, 3.81 mm (0.150 inch) ID tubing and a flanged Easy-Lock Connector. This device is indicated for the personal cycler peritoneal dialysis system used for automatic control of dialysate solution exchanges in the treatment of renal failure patients undergoing peritoneal dialysis. FDA UDI
- Model / Reference
- 5C4136 FDA UDI
- Description
- This adapter consists of a spike connector, approx. 10.15 cm (4 inch) long, 3.81 mm (0.150 inch) ID tubing and a flanged Easy-Lock Connector. This device is indicated for the personal cycler peritoneal dialysis system used for automatic control of dialysate solution exchanges in the treatment of renal failure patients undergoing peritoneal dialysis. FDA UDI
Identifiers
- Catalog Number
- 5C4136 FDA UDI
- Primary DI / UDI-DI
- 00085412050829 FDA UDI
- 510(k) Number
- K923065 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
Yes
FDA UDI
Category: Peritoneal dialysis system tubing set
Easy-Lock by Baxter Healthcare Corp — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K923065 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 Healthcare Corp
Sources (1)
- FDA UDI 4144d8ee-71b5-471d-b365-be4eccda5158 37 fields · synced Jun 8, 2026