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NEPHROS, INC.

Last updated September 17, 2026

Information

Country: US
Address: 380 Lackawana Place, South Orange, NJ, 07079
Website: nephros.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: 201-345-0829
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 3003337893
DUNS Number: 120664557

Catalogue (63)

Page 1 of 2

Device	Model / Reference	Registries	Class	Status
S100 Handheld quick connect	70-0287	FDA UDI	Class II	Unknown
Nephros S100 Sink Spout	70-0280	FDA UDI	Class II	Active
H2H Rinse Line	70-5827	FDA UDI	Class II	Unknown
Nephros HydraGuard 10” UltraFilter	70-0111	FDA UDI	Class II	Active
Nephros SSU-H UltraFilter	70-0283	FDA UDI	Class II	Active
DSU Dome Dialysis	70-0235D	FDA UDI	Class II	Unknown
Nephros EndoPur Endotoxin 20” Filter Flat	70-0120H	FDA UDI	Class II	Active
Nephros S100 Shower Handheld	70-0282	FDA UDI	Class II	Active
Nephros EndoPur Endotoxin 10” Filter	70-0110H	FDA UDI	Class II	Active
Nephros S100 Sink Spray	70-0281	FDA UDI	Class II	Active
SSU Dome Dialysis	70-0243D	FDA UDI	Class II	Unknown
DSU-H Thread	70-0286	FDA UDI	Class II	Unknown
TQE Plus Endotoxin 20" Filter Flat 222 Head	TQE0.005-20HP3E	FDA UDI	Class II	Active
S100 Sink Spout	70-0280	FDA UDI	Class II	Unknown
EndoPur Endotoxin 10" Filter	70-0110	FDA UDI	Class II	Unknown
Filtro de Endotoxina Nephros EndoPur (plano) 10"	70-0110P	FDA UDI	Class II	Active
TQE Plus Endotoxin 30" Filter Flat 222 Head	TQE0.005-30P3E	FDA UDI	Class II	Unknown
SSUmini JG 3/8	70-0251C	FDA UDI	Class II	Unknown
SSU-D with Orifice	70-0243O	FDA UDI	Class II	Unknown
SSUmini JG	70-0251	FDA UDI	Class II	Unknown
HydraGuard 10” UltraFilter - Flushable	70-0111F	FDA UDI	Class II	Unknown
Nephros HydraGuard 10” UltraFilter – Flush	70-0112	FDA UDI	Class II	Active
Nephros DSU-H UltraFilter	70-0286	FDA UDI	Class II	Active
SSU-H Thread	70-0284	FDA UDI	Class II	Unknown
Filtro de Endotoxina Nephros EndoPur (plano) 20"	70-0120P	FDA UDI	Class II	Active
DSU-H Quick Connect	70-0285	FDA UDI	Class II	Unknown
TQE Plus Endotoxin 10" Filter Flat 222 Head	TQE0.005-10P3E	FDA UDI	Class II	Unknown
S100 Handheld thread	70-0282	FDA UDI	Class II	Unknown
H2H Substitution Filter	70-6828	FDA UDI	Class II	Unknown
SSU-H Quick Connect	70-0283	FDA UDI	Class II	Unknown
Nephros DSU-H UltraFilter	70-0285	FDA UDI	Class II	Active
Nephros SSU-D UltraFilter	70-0243D	FDA UDI	Class II	Active
Nephros SSUmini JG UltraFiltro	70-0251P	FDA UDI	Class II	Active
SSU-D with Orifice	70-0243O	FDA UDI	Class II	Unknown
MarCor ENX Hollow Fiber Capsule UltraFilter	W2T912244	FDA UDI	Class II	Active
Nephros SSUmini UltraFiltro	70-0242P	FDA UDI	Class II	Active
EndoPur Endotoxin 30" Filter	70-0130	FDA UDI	Class II	Unknown
Nephros SSU-H UltraFilter	70-0284	FDA UDI	Class II	Active
SSUmini thread	70-0242	FDA UDI	Class II	Unknown
Nephros DSU-D UltraFilter	70-0235D	FDA UDI	Class II	Active
TQE Plus Endotoxin 20" Filter Flat 222 Head	TQE0.005-20P3E	FDA UDI	Class II	Unknown
Nephros SSUmini JG UltraFilter	70-0251	FDA UDI	Class II	Active
EndoPur Endotoxin 20" Filter	70-0120	FDA UDI	Class II	Unknown
TQE Plus Endotoxin 10" Filter Flat 222 Head	TQE0.005-10HP3E	FDA UDI	Class II	Active
EndoPur Endotoxin 40" Filter	70-0140	FDA UDI	Class II	Unknown
S100 Sink Spray	70-0281	FDA UDI	Class II	Unknown
DSU-H Quick Connect (Polypropylene)	70-0285P	FDA UDI	Class II	Unknown
DSU-H Thread (Polyproplyene)	70-0286P	FDA UDI	Class II	Unknown
SSU Dome Thread Dialysis	70-0244D	FDA UDI	Class II	Unknown
H2H Infusion Set	70-5828	FDA UDI	Class II	Unknown

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FDA Recalls (3)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Oct 28, 2013	Z-0488-2014	—	terminated	Promotional materials for non-medical water filtration products were determined to promote claims which constitute marketing the product as a medical device.
Oct 28, 2013	Z-0490-2014	—	terminated	Promotional materials for non-medical water filtration products were determined to promote claims which constitute marketing the product as a medical device.
Oct 28, 2013	Z-0487-2014	—	terminated	Promotional materials for non-medical water filtration products were determined to promote claims which constitute marketing the product as a medical device.