Catalog Number

02.0077

Brand Name

TDS Standard Solution

Version/Model Number

02.0077

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

a91e9d34-31cf-4b30-9f8b-c6c517a796a1

Public Version Date

May 12, 2020

Public Version Number

1

DI Record Publish Date

May 04, 2020

Package DI Number

M985020583

Quantity per Package

12

Contains DI Package

M985020077

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton