S100 Handheld thread

GUDID 10896241002562

The S100 Point of Use Filter is a disposable point-of-use micro-filter used to filter EPA quality drinking water. The filter retains bacteria. By retaining bacteria in water for washing and drinking, the filter may aid in infection control. The filter produces water that is suitable for cleaning of equipment used in medical procedures and washing of surgeon’s hands.

NEPHROS, INC.

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Primary Device ID10896241002562
NIH Device Record Keye5d6718e-0848-4174-814c-bc1e2e479403
Commercial Distribution StatusIn Commercial Distribution
Brand NameS100 Handheld thread
Version Model Number70-0282
Company DUNS120664557
Company NameNEPHROS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100896241002565 [Primary]
GS110896241002562 [Package]
Contains: 00896241002565
Package: Carton Box [6 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHVSystem, Water Purification, General Medical Use

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2021-09-14
Device Publish Date2016-09-22

Devices Manufactured by NEPHROS, INC.

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10896241002074 - H2H Substitution Filter2021-09-17 H2H Substitution Filter and packaging information
10896241002081 - H2H Water Filter2021-09-17 H2H Water Filter and packaging information
10896241002326 - SSU-H Quick Connect2021-09-17 The Nephros SSU-H is a disposable in-line water ultrafilter used to filter EPA quality drinking water. The filter retains bacter
10896241002333 - SSU-H Thread2021-09-17 The Nephros SSU-H is a disposable in-line water ultrafilter used to filter EPA quality drinking water. The filter retains bacter
10896241002364 - H2H Rinse Line2021-09-17 H2H Rinse Line and packaging information
10896241002586 - S100 Handheld quick connect2021-09-17 S100 Handheld quick connect and packaging information

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