FDA.reportPublic FDA data

Nephros SSUmini JG UltraFiltro

Primary DI
10896241002623
Brand
Nephros SSUmini JG UltraFiltro
Company
NEPHROS, INC.
Model
70-0251P
Device description
The Nephros SSUmini JG UltraFiltro is intended to be used to filter water or bicarbonate concentrate used in hemodialysis devices. It assists in providing hemodialysis quality water or bicarbonate concentrate. The device is not a complete water treatment system but serves to remove biological contaminants. Therefore it must be used in conjunction with other water treatment equipment (RO, DI, etc.).
Published
2024-02-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FIPSubsystem, Water Purification

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FIPSubsystem, Water PurificationGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K110285000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K110285000NEPHROS DSU FILTER, NEPHROS MSU FILTER, NEPHROS SSU FILTERNephros, Inc.2011-07-14FIP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10896241002623PackageGS11In Commercial Distribution
20896241002620PackageGS110In Commercial Distribution
00896241002626PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1089624100262310896241002623
2089624100262020896241002620
00896241002626008962410026268962410026260896241002626

GMDN Terms#

Term, Definition table
TermDefinition
Haemodialysis system dialysate pyrogen filterA sterile device designed to be used with a haemodialysis system for filtration of dialysate during haemodialysis to remove bacteria and endotoxins and produce purified dialysate for the procedure. It may perform secondary safety filtering to prepare on-line substitution solution that can be infused into the patient to compensate for loss of fluid volume resulting from haemodialysis. It typically consists of a plastic housing, containing a hollow fibre membrane, with appropriate connectors at either end. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
201-345-0829vashone.thomas@nephros.com

Regulatory Flags#

DUNS number
120664557
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00866318000305SSUmini JG 3/870-0251C2017-12-31
00866318000350"EndoPur Endotoxin 10"" Filter"70-01102017-07-18
00866318000367"EndoPur Endotoxin 10"" Filter Fin"70-0110F2017-09-29
00866318000374"EndoPur Endotoxin 20"" Filter "70-01202017-07-18
00896241002121DSU Dome Dialysis70-0235D2016-09-22
00896241002138Nephros DSU-D UltraFilter70-0235D2021-09-16
00896241002206SSUmini thread70-02422016-09-24
00896241002213SSU Dome Dialysis70-0243D2016-09-24
00896241002220Nephros SSU-D UltraFilter70-0243D2021-09-16
00896241002251SSU Dome Thread Dialysis70-0244D2016-09-24
00896241002503SSU-D with Orifice70-0243O2016-09-24
00896241002510SSU-D with Orifice70-0243O2021-09-16
00896241002596SSUmini JG70-02512016-09-24
00896241002619Nephros SSUmini JG UltraFilter70-02512024-02-13
00896241002626Nephros SSUmini JG UltraFiltro70-0251P2024-02-13
00896241002664"EndoPur Endotoxin 30"" Filter "70-01302017-07-18
00896241002671"EndoPur Endotoxin 40"" Filter "70-01402017-07-18
00896241002237Nephros SSUmini UltraFilter70-02422024-02-13
00896241002244Nephros SSUmini UltraFiltro70-0242P2024-02-13
10896241002616Nephros SSUmini JG UltraFilter70-02512024-02-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00817927020345AmeriWater Chemical Feed SystemAMERIWATER, LLCFIP2026-05-08
00817927020352AmeriWater Chemical Feed SystemAMERIWATER, LLCFIP2026-05-08
00817927020369AmeriWater Chemical Feed SystemAMERIWATER, LLCFIP2026-05-08
00817927020376AmeriWater Chemical Feed SystemAMERIWATER, LLCFIP2026-05-08
00817927020383AmeriWater® Alarm PanelAMERIWATER, LLCFIP2026-05-08
00817927020390AmeriWater® Alarm PanelAMERIWATER, LLCFIP2026-05-08
00817927020406AmeriWater® Alarm PanelAMERIWATER, LLCFIP2026-05-08
00817927020413AmeriWater® Alarm PanelAMERIWATER, LLCFIP2026-05-08
04039361261313DIASAFE®plusUSFresenius Medical Care AGFIP2026-05-01
00850001011266Tablo(R) Hemodialysis SystemOutset Medical, Inc.FIP2025-09-21
00850001011341Tablo(R) Hemodialysis SystemOutset Medical, Inc.FIP2025-09-21
00850001011358Tablo(R) Hemodialysis SystemOutset Medical, Inc.FIP2025-09-21
00860008016942Moda-flx Hemodialysis SystemDiality IncFIP2025-07-16
00860008016973Moda-flx Hemodialysis SystemDiality IncFIP2025-07-16
00860008016904Moda-flx Hemodialysis SystemDiality IncFIP2025-07-16
00860008016911Moda-flx Hemodialysis SystemDiality IncFIP2025-07-16
00860008016928Moda-flx Hemodialysis SystemDiality IncFIP2025-07-16
00860008016959Moda-flx Hemodialysis SystemDiality IncFIP2025-07-16
00860008016966Moda-flx Hemodialysis SystemDiality IncFIP2025-07-16
RO0258E-2436RO, 8640GPD, 208V, 4MEMBETTER WATER, LLCFIP2024-11-13
PB0002MEDI-PORT PBII R.O. 220VBETTER WATER, LLCFIP2024-11-13
PB0003MEDI-PORT PBII R.O. 120VBETTER WATER, LLCFIP2024-11-13
PR0023"PRETREAT, 1"", 208V, CPVC, SHORT, AC"BETTER WATER, LLCFIP2024-11-13
PS0155"POST-TREAT, .03 30"", 208V"BETTER WATER, LLCFIP2024-11-13
04251285200524AquaB LITEVIVONIC GmbHFIP2024-07-25
04251285200531AquaB LITEVIVONIC GmbHFIP2024-07-25
04251285200548AquaB LITEVIVONIC GmbHFIP2024-07-25
04251285200555AquaB LITEVIVONIC GmbHFIP2024-07-25
04251285200562AquaB LITEVIVONIC GmbHFIP2024-07-25
04251285200579AquaB LITEVIVONIC GmbHFIP2024-07-25