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Dual Lumen Extended Length Catheter (11cm) and GALT Insertion Kit

FDA UDI

Class II (US FDA UDI)

by Nuwellis, Inc.

Identity

Trade Name
Dual Lumen Extended Length Catheter (11cm) and GALT Insertion Kit FDA UDI
Generic Name
Double-lumen haemodialysis catheter, nonimplantable FDA UDI
Device Name
This Kit includes a dELC Catheter (11cm) and a GALT Insertion Kit. 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
320111 FDA UDI
Description
This Kit includes a dELC Catheter (11cm) and a GALT Insertion Kit. 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
320111 FDA UDI
Primary DI / UDI-DI
10853072007210 FDA UDI
FDA Product Code
MPB FDA UDI
NQJ 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

Yes

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

Dimensions & Sizes

Size
Catheter Working Length — 11 Centimeter FDA UDI

Category: Double-lumen haemodialysis catheter, nonimplantable

Dual Lumen Extended Length Catheter (11cm) and GALT Insertion Kit by Nuwellis, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Double-lumen haemodialysis catheter, nonimplantable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Nuwellis, Inc.

Sources (1)

  • FDA UDI 36974163-3d16-46e5-9c83-3b1dc52befec 37 fields · synced Jun 1, 2026