Catalog Number

-

Brand Name

EP1 VP Test Pressure Kit, Single

Version/Model Number

730-001

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

EXQ

Product Code Name

Cystometer, Electrical Recording

Public Device Record Key

d74bf38e-f6f0-4ba3-b6ea-016f785b8169

Public Version Date

November 30, 2018

Public Version Number

1

DI Record Publish Date

October 30, 2018

Package DI Number

10890477000316

Quantity per Package

10

Contains DI Package

00890477000319

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-