Identity
- Trade Name
- Xcela FDA UDI
- Generic Name
- Vascular port/catheter FDA UDI
- Device Name
- Xcela Plus Plastic Port with Filled Suture Holes and 8F x 63cm Polyurethane Catheter FDA UDI
- Model / Reference
- 44032 FDA UDI
- Description
- Xcela Plus Plastic Port with Filled Suture Holes and 8F x 63cm Polyurethane Catheter FDA UDI
Identifiers
- Primary DI / UDI-DI
- H965440320 FDA UDI
- FDA Product Code
- LJT FDA UDI
- GMDN Term
- Vascular port/catheter FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5965 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
MR Conditional FDA UDI
Dimensions & Sizes
- Size
- Needle Gauge — 18 Gauge FDA UDILumen/Inner Diameter — 1.6 Millimeter FDA UDILength — 63 Centimeter FDA UDIPressure — 300 Pound per Square Inch FDA UDICatheter Gauge — 8 French FDA UDIOuter Diameter — 2.6 Millimeter FDA UDI
Xcela by Navilyst Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Navilyst Medical, Inc.
Sources (1)
- FDA UDI 405b69ff-db0d-4acc-a548-dd3137746eef 36 fields · synced Jun 8, 2026