Catalog Number

02.0075

Brand Name

TDS Standard Solution

Version/Model Number

02.0075

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K191496,K191496

Product Code

FKH

Product Code Name

Solution-Test Standard-Conductivity, Dialysis

Public Device Record Key

2fae363c-78f9-4983-92d6-5d5808328d56

Public Version Date

May 12, 2020

Public Version Number

1

DI Record Publish Date

May 04, 2020

Package DI Number

M985020081

Quantity per Package

6

Contains DI Package

M985020075

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton