Catalog Number

BSP-307-25-00

Brand Name

Status BTA Card

Version/Model Number

BSP-307-25-00

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

K974845

Product Code

MMW

Product Code Name

System, Test, Tumor Marker, Monitoring, Bladder

Public Device Record Key

5dc79c14-1087-401f-a85c-925eb86038bd

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

November 30, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-