FDA.reportPublic FDA data

HydraGuard 10” UltraFilter - Flushable

Primary DI
00866318000336
Brand
HydraGuard 10” UltraFilter - Flushable
Company
NEPHROS, INC.
Model
70-0111F
Device description
The HydraGuard 10” UltraFilter - Fin is intended to be used to filter EPA quality drinking water. The filter retains bacteria, viruses and endotoxin. By providing ultrapure water for washing and drinking, the filter aids in infection control. The filter produces water that is suitable for wound cleansing, cleaning of equipment used in medical procedures and washing of surgeon’s handsContraindications:Medical: The filter is not intended to provide water that can be used as a substitute for USP sterile water.
Published
2017-07-18
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
NHVSystem, Water Purification, General Medical Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NHVSystem, Water Purification, General Medical UseGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K161467000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K161467000HydraGuard 10 UltraFilterNephros, Inc.2016-12-22NHV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10866318000333PackageGS11Not in Commercial Distribution
20866318000330PackageGS130Not in Commercial Distribution
00866318000336PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086631800033310866318000333
2086631800033020866318000330
00866318000336008663180003368663180003360866318000336

GMDN Terms#

Term, Definition table
TermDefinition
Particulate water purification filterA device designed to remove sediment and other suspended particles from flowing water by creating a mechanical barrier to elements larger than a specified size (e.g., 5 to 10 microns/micrometres); it is often made of polypropylene filaments.

Regulatory Flags#

DUNS number
120664557
Device count
1
Lot or batch
true
Expiration date on label
true

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
03760279733234Disposable water filter Filt'RayAQUATOOLSNHV2024-05-15
03760279733265Disposable water filter Filt'RayAQUATOOLSNHV2024-05-15
03760279733296Disposable water filter Filt'RayAQUATOOLSNHV2024-05-15
03760279733333Disposable water filter Filt'RayAQUATOOLSNHV2024-05-15
03760279733371Disposable water filter Filt'RayAQUATOOLSNHV2024-05-15
03760279733401Disposable water filter Filt'RayAQUATOOLSNHV2024-05-15
03760279733449Disposable water filter Filt'RayAQUATOOLSNHV2024-05-15
03760279733470Disposable water filter Filt'RayAQUATOOLSNHV2024-05-15
03760279733500Disposable water filter Filt'RayAQUATOOLSNHV2024-05-15
00896241002091DSU-H Quick Connect (Polypropylene)NEPHROS, INC.NHV2022-03-11
00896241002107DSU-H Thread (Polyproplyene)NEPHROS, INC.NHV2022-03-11
10896241002098DSU-H Quick Connect (Polypropylene)NEPHROS, INC.NHV2022-03-11
10896241002104DSU-H Thread (Polyproplyene)NEPHROS, INC.NHV2022-03-11
03760279730011Disposable Water Filter FILTRAY 2GAQUATOOLSNHV2021-11-05
03760279730073Disposable Water Filter FILTRAY 2GAQUATOOLSNHV2021-11-05
03760279730080Disposable Water Filter FILTRAY 2GAQUATOOLSNHV2021-11-05
03760279730103Disposable Water Filter FILTRAY 2GAQUATOOLSNHV2021-11-05
03760279730110Disposable Water Filter FILTRAY 2GAQUATOOLSNHV2021-11-05
03760279731100Disposable Water Filter FILTRAY 2GAQUATOOLSNHV2021-11-05
03760279731117Disposable Water Filter FILTRAY 2GAQUATOOLSNHV2021-11-05
03760279731124Disposable Water Filter FILTRAY 2GAQUATOOLSNHV2021-11-05
03760279731131Disposable Water Filter FILTRAY 2GAQUATOOLSNHV2021-11-05
03760279731148Disposable Water Filter FILTRAY 2GAQUATOOLSNHV2021-11-05
03760279731155Disposable Water Filter FILTRAY 2GAQUATOOLSNHV2021-11-05
03760279731162Disposable Water Filter FILTRAY 2GAQUATOOLSNHV2021-11-05
03760279731179Disposable Water Filter FILTRAY 2GAQUATOOLSNHV2021-11-05
03760279731186Disposable Water Filter FILTRAY 2GAQUATOOLSNHV2021-11-05
03760279731193Disposable Water Filter FILTRAY 2GAQUATOOLSNHV2021-11-05
03760279730004Disposable Water Filter FILTRAY 2GAQUATOOLSNHV2021-11-05
03760279730400Disposable Water Filter FILTRAY 2GAQUATOOLSNHV2021-11-05