Catalog Number

-

Brand Name

One+Step pH

Version/Model Number

8174

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 03, 2022

Issuing Agency

In GS1

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

CEN

Product Code Name

Dye-Indicator, Ph (Urinary, Non-Quantitative)

Public Device Record Key

a4cb620a-7ab3-4bb2-ba84-1fc03baaad0a

Public Version Date

October 11, 2022

Public Version Number

1

DI Record Publish Date

October 03, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-