Identity
- Trade Name
- Dual Lumen Extended Length Catheter (15cm) FDA UDI
- Generic Name
- Double-lumen haemodialysis catheter, nonimplantable FDA UDI
- Device Name
- The dELC is a 6 F reverse taper dual lumen venous access device with stainless steel coil reinforcement, designed specifically for use with the Aquadex systems. The catheter is inserted into the peripheral venous circulation by way of a peel away introducer. FDA UDI
- Model / Reference
- 320102 FDA UDI
- Description
- The dELC is a 6 F reverse taper dual lumen venous access device with stainless steel coil reinforcement, designed specifically for use with the Aquadex systems. The catheter is inserted into the peripheral venous circulation by way of a peel away introducer. FDA UDI
Identifiers
- Catalog Number
- 320102 FDA UDI
- Primary DI / UDI-DI
- 10853072007173 FDA UDI
- FDA Product Code
- MPB FDA UDINQJ FDA UDI
- GMDN Term
- Double-lumen haemodialysis catheter, nonimplantable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5540 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
MR Unsafe FDA UDI
Dimensions & Sizes
- Size
- Catheter Working Length — 15 Centimeter FDA UDI
Category: Double-lumen haemodialysis catheter, nonimplantable
Dual Lumen Extended Length Catheter (15cm) by Nuwellis, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Nuwellis, Inc.
Sources (1)
- FDA UDI c99be9b7-a85c-4212-b98d-592e9332ed17 37 fields · synced May 31, 2026