Catalog Number

811916

Brand Name

Sterichek® BiCarb pH Reagent Strips

Version/Model Number

811916

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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"

-

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

K031267,K031267

Product Code

MNV

Product Code Name

Strip, Dialysate Ph Indicator

Public Device Record Key

ca4b5995-b3da-4d68-8c10-d3e1ad827ebb

Public Version Date

September 12, 2018

Public Version Number

4

DI Record Publish Date

October 28, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-