FDA.reportPublic FDA data

DSU-H Quick Connect

Primary DI
10896241002340
Brand
DSU-H Quick Connect
Company
NEPHROS, INC.
Model
70-0285
Device description
DSU-H Quick Connect and packaging information
Published
2016-09-24
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
false

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
K141731000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141731000NEPHROS DSU-H, NEPHROS SSU-HNephros, Inc.2014-10-24NHV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10896241002340PackageGS11In Commercial Distribution
20896241002347PackageGS19In Commercial Distribution
00896241002343PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1089624100234010896241002340
2089624100234720896241002347
00896241002343008962410023438962410023430896241002343

GMDN Terms#

Term, Definition table
TermDefinition
Microbial water purification filter, non-sterilizableA sterile device designed to remove bacteria and other suspended particles from flowing water by creating a mechanical barrier to elements larger than 0.2 micrometres. It typically consists of a plastic housing with a connector to the water source [e.g., a tap (faucet)] and a 0.2 micrometre filtering membrane [e.g., made of nylon, polyvinylidene fluoride (PVDF), or polyethersulfone (PES)]; a prefiltration of the water to remove larger particles is typically recommended. It is typically used for hygienic and surgical hand washing, wound irrigation, and/or rinsing of medical devices. This is a disposable, non-sterilizable device which may serve multiple patients before being discarded.

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

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