AccessGUDID - DEVICE: Nephros S100 Shower Handheld (00896241002572)

GUDID

Device Identifier (DI) Information

Brand Name: Nephros S100 Shower Handheld
Version or Model: 70-0282
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: NEPHROS, INC.

Primary DI Number: 00896241002572
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 120664557 *Terms of Use

Device Description: The Nephros S100 Shower Handheld 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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
58088	Microbial water purification filter, non-sterilizable	A 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NHV	System, Water Purification, General Medical Use

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K153084	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b9955a3e-608c-4ed2-99e8-46cd10a70ddb
Public Version Date: February 14, 2024
Public Version Number: 2
DI Record Publish Date: September 16, 2021