AccessGUDID - DEVICE: POSTTREAT, 3UF, 208V (PS0102)

GUDID

Device Identifier (DI) Information

Brand Name: POSTTREAT, 3UF, 208V
Version or Model: WM-PST-255-00-2GJ
Commercial Distribution Status: In Commercial Distribution
Catalog Number: WM-PST-255-00-2GJ
Company Name: BETTER WATER, LLC

Primary DI Number: PS0102
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 055252159 *Terms of Use

Device Description: Wall-mounted post-treatment for water purification for dialysis applications. Includes three ultra-filters, and two pumps. 208V.

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?
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
FIP	Subsystem, Water Purification

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K920186	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: ed78e2cc-5175-4807-b3a5-1bdffab8292f
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: October 13, 2016