Identity
- Trade Name
- Lyka® PORT Needle Free Access Device FDA UDI
- Generic Name
- Haemodialysis tubing valve-connector FDA UDI
- Model / Reference
- 4170Y FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00634624417021 FDA UDI
- 510(k) Number
- K241058 FDA UDI
- FDA Product Code
- FPA FDA UDI
- GMDN Term
- Haemodialysis tubing valve-connector FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5440 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: Haemodialysis tubing valve-connector
Lyka® PORT Needle Free Access Device by Quest Medical Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Haemodialysis tubing valve-connector.
- Tego™ — ICU MEDICAL, INC. · Class II
- Tego™ — ICU MEDICAL, 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 |
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Manufacturer
- Manufacturer
- Quest Medical Inc
Sources (1)
- FDA UDI d744711c-518f-46bc-adbb-3763e2645e5e 34 fields · synced May 30, 2026