DIASOL - Dialysate Additive 6.3 grams Calcium Chloride to - DIASOL, INC.

Duns Number:068434658

Device Description: Dialysate Additive 6.3 grams Calcium Chloride to increase Calcium by 0.5mEq/L when added t Dialysate Additive 6.3 grams Calcium Chloride to increase Calcium by 0.5mEq/L when added to 3.785 liters of concentrate proportioned at 1:44

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More Product Details

Catalog Number

CC4

Brand Name

DIASOL

Version/Model Number

CC6.3

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

Yes

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

K020231,K020231

Product Code Details

Product Code

KPO

Product Code Name

Dialysate Concentrate For Hemodialysis (Liquid Or Powder)

Device Record Status

Public Device Record Key

6706e645-07cb-4208-bbb3-f461cad846be

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

April 28, 2017

Additional Identifiers

Package DI Number

B467CC63170

Quantity per Package

170

Contains DI Package

B467CC63

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE

"DIASOL, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 36