AccessGUDID - DEVICE: MEDI-PORT PBII R.O. 220V (PB0002)

GUDID

Device Identifier (DI) Information

Brand Name: MEDI-PORT PBII R.O. 220V
Version or Model: EQROPB01600
Commercial Distribution Status: In Commercial Distribution
Catalog Number: EQROPB01600
Company Name: BETTER WATER, LLC

Primary DI Number: PB0002
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 055252159 *Terms of Use

Device Description: Portable reverse osmosis machine for water purification for dialysis applications. 220V.

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?
44344	Combination water purification system	An assembly of electrically-powered devices, or stand-alone device, designed to remove unwanted chemical, particulate, and/or biological contaminants from water. This system purifies water using a combination of methods including particulate filtration, chemical disinfection, deionization, reverse osmosis, and/or ultraviolet light.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FIP	Subsystem, Water Purification

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K954928	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: 2ff9e8e3-3eed-4bf3-8e83-1faaae2f81cb
Public Version Date: November 21, 2024
Public Version Number: 1
DI Record Publish Date: November 13, 2024