Catalog Number

E570-0395

Brand Name

BladderScan®

Version/Model Number

Prime Plus™

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

-

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

K153101,K153101

Product Code

ITX

Product Code Name

Transducer, Ultrasonic, Diagnostic

Public Device Record Key

99a468ca-2286-4e45-9a21-b8727ccc9e05

Public Version Date

November 08, 2021

Public Version Number

1

DI Record Publish Date

October 29, 2021

Package DI Number

10879123008012

Quantity per Package

1

Contains DI Package

00879123008015

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case