FDA.reportPublic FDA data

H2H Infusion Set

Primary DI
10896241002067
Brand
H2H Infusion Set
Company
NEPHROS, INC.
Model
70-5828
Device description
H2H Infusion Set and packaging information
Published
2016-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

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
K112314000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K112314000NEPHROS OLPUR H2H HEMODIAFILTRATION (HDF) MODULE AND OLPUR MD 220 HEMODIAFILTERNephros, Inc.2012-04-27KDI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10896241002067PackageGS125Not in Commercial Distribution
00896241002060PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1089624100206710896241002067
00896241002060008962410020608962410020600896241002060

GMDN Terms#

Term, Definition table
TermDefinition
Basic intravenous administration set, noninvasiveA collection of noninvasive devices intended to conduct fluids from an intravenous (IV) administration bag/bottle to a peripheral venous cannula (not included) during gravitational or pump administration to a patient's venous system; some types may in addition be intended for enteral feeding applications. It typically includes tubing, connectors, chambers, and clamps; the bag/bottle may be included. It neither includes devices intended for invasive use nor a heat exchanger. This is a single-use device.

Sterilization Methods#

Method table
Method

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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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