BICARB, SINGLE, 60, MIX/DEL - Bicarbonate mixer with a single 100 gallon tank, - BETTER WATER, LLC

Duns Number:055252159

Device Description: Bicarbonate mixer with a single 100 gallon tank, for central mix and delivery in dialysis Bicarbonate mixer with a single 100 gallon tank, for central mix and delivery in dialysis applications.

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More Product Details

Catalog Number

EQASSY60BC-1TNK

Brand Name

BICARB, SINGLE, 60, MIX/DEL

Version/Model Number

EQASSY60BC-1TNK

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

MRI safety Status

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)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K992793

Product Code Details

Product Code

FIN

Product Code Name

Tank, Holding, Dialysis

Device Record Status

Public Device Record Key

be6d0061-e187-47ba-9fc5-86522c33099f

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 13, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BETTER WATER, LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 77