AccessGUDID - DEVICE: Nephros HydraGuard 10” UltraFilter (00866318000329)

GUDID

Device Identifier (DI) Information

Brand Name: Nephros HydraGuard 10” UltraFilter
Version or Model: 70-0111
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: NEPHROS, INC.

Primary DI Number: 00866318000329
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 120664557 *Terms of Use

Device Description: The Nephros HydraGuard 10” UltraFilter 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 hands Contraindications: Medical: The filter is not intended to provide water that can be used as a substitute for USP sterile water.

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):	No
Over the Counter (OTC):	Yes
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?
35433	Particulate water purification filter	A 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.	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 [?]
K161467	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
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: e381828d-e908-42e4-a0dc-114a581699ea
Public Version Date: February 14, 2024
Public Version Number: 6
DI Record Publish Date: July 19, 2017