AccessGUDID - DEVICE: BICARB, DUAL, 60, MIX/DEL, EDUCTOR (BC0121)

GUDID

Device Identifier (DI) Information

Brand Name: BICARB, DUAL, 60, MIX/DEL, EDUCTOR
Version or Model: EQASSY60BC-2TNK-EB
Commercial Distribution Status: In Commercial Distribution
Catalog Number: EQASSY60BC-2TNK-EB
Company Name: BETTER WATER, LLC

Primary DI Number: BC0121
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 055252159 *Terms of Use

Device Description: Bicarbonate mixer with dual 60 gallon tanks, for central mix and delivery in dialysis applications. Uses an eductor pump to mix.

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?
36345	Haemodialysis bicarbonate solution preparation mixer	An electrically-powered unit intended to mix a bicarbonate concentrate(s), commonly in powder form, with water to produce a bicarbonate haemodialysis solution. It typically includes tanks with connection hoses, controls and display; some types may include solution delivery features.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FIN	Tank, Holding, Dialysis

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K992793	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: 0b3b4479-ecff-4986-bf62-29bc1c78ffef
Public Version Date: November 21, 2024
Public Version Number: 1
DI Record Publish Date: November 13, 2024