Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007137787

FEI Number

3007137787

Entity Name

Nuwellis, Inc.

City/State/Country

Eden Prairie, MN, US

Establishment Address

12988 Valley View Rd, Eden Prairie, MN 55344, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device

Owner / Operator

Nuwellis, Inc. (Owner Number: 10026935)

Owner / Operator Contact Address

12988 Valley View Road, Eden Prairie, MN 55344, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K071854

PMA Number

N/A

All Registered Proprietary Names

Aquadex SmartFlow dELC Aquadex FlexFlow Aquadex SmartFlow dELC Aquadex Flexflow

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KDI	Dialyzer, High Permeability With Or Without Sealed Dialysate System	Gastroenterology, Urology	Class 2	876.5860	2020-02-26
NQJ	Catheter, Hemodialysis, Non-Implanted, Ultrafiltration, For Peripheral Use	Gastroenterology, Urology	Class 2	876.5540	2025-08-14
MPB	Catheter, Hemodialysis, Non-Implanted	Gastroenterology, Urology	Class 2	876.5540	2025-08-14
NQJ	Catheter, Hemodialysis, Non-Implanted, Ultrafiltration, For Peripheral Use	Gastroenterology, Urology	Class 2	876.5540	2024-01-10
MSD	Catheter, Hemodialysis, Implanted	Gastroenterology, Urology	Class 2	876.5540	2024-01-10
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2024-01-10
PND	Midline Catheter	General Hospital	Class 2	880.5200	2024-01-10
MPB	Catheter, Hemodialysis, Non-Implanted	Gastroenterology, Urology	Class 2	876.5540	2024-01-10
KDI	Dialyzer, High Permeability With Or Without Sealed Dialysate System	Gastroenterology, Urology	Class 2	876.5860	2016-09-22

Official Correspondent

Dawn Li

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Nuwellis, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K811830	Cordis Corp.	C-DAK DUO-FLUX ARTIFICIAL KIDNEY	1981-09-21
K070320	Edwards Lifesciences Services GmbH	EDWARDS AQUARIUS HEMOFILTRATION SYSTEM, MODEL ABM 01	2007-06-07
K150880	Outset Medical	Tablo Console with Wireless Capability	2015-05-01
K171618	Medcomp (Dba Medical Components, Inc.)	Symetrex Long Term Hemodialysis Catheter	2017-11-16
K111817	Covidien	PALINDROME RT CHRONIC CATHETER	2011-08-30

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0019-2025	Outset Medical, Inc.	2	Tablo Console, REF: PN-0003000, PN-0006000, part of the Tablo Hemodialysis System. The Tablo Hemodialysis System is indicated for use in patients with acute and/or chronic renal failure, with or without ultrafiltration, in an acute or chronic care facility.
Z-0028-2024	Fresenius Medical Care Holdings, Inc.	2	2008T Hemodialysis SYS, with CDX
Z-0029-2024	Fresenius Medical Care Holdings, Inc.	2	2008T Hemodialysis System without CDX
Z-0030-2024	Fresenius Medical Care Holdings, Inc.	2	2008T Hemodialysis System w/Bibag
Z-0031-2024	Fresenius Medical Care Holdings, Inc.	2	2008T GEN 2 Bibag without CDX

Similar Registrations

Registration Number	Establishment Name	Location
3015349756	DIALITY, INC.	Irvine, CA, US
9611824	FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH	SCHWEINFURT Bavaria, DE
3012149633	LIDER	MONTREVEL EN BRESSE Auvergne-Rhone-Alpes, FR
3005695808	SARMED SRL	IGLESIAS Sardegna, IT
1649518	Sterigenics US LLC	Fort Worth, TX, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007137787. Last updated year: 2026. Please use registration number 3007137787 when referencing this establishment in official correspondence.