FDA.reportPublic FDA data

H2H Substitution Filter

Primary DI
10896241002074
Brand
H2H Substitution Filter
Company
NEPHROS, INC.
Model
70-6828
Device description
H2H Substitution Filter 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
10896241002074PackageGS15Not in Commercial Distribution
20896241002071PackageGS120Not in Commercial Distribution
00896241002077PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1089624100207410896241002074
2089624100207120896241002071
00896241002077008962410020778962410020770896241002077

GMDN Terms#

Term, Definition table
TermDefinition
Haemodialysis system dialysate pyrogen-filtration setA collection of sterile devices designed to be used with a haemodialysis system for on-line filtration of the dialysate to remove bacteria and endotoxins during haemodialysis. This purified (filtered) dialysate is used for the replacement fluid (substitution solution). It includes tubing with an integrated filter(s), and typically connectors (e.g., Luer-lock) and a sampling port. 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
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PS0155"POST-TREAT, .03 30"", 208V"BETTER WATER, LLCFIP2024-11-13
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