Catalog Number

RMD-001

Brand Name

mcompass Anorectal Manometry System

Version/Model Number

RMD-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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K120088,K120088

Product Code

KLA

Product Code Name

Monitor, Esophageal Motility, And Tube

Public Device Record Key

0cd4a39c-a42f-4f29-9fad-1d23290216db

Public Version Date

November 08, 2019

Public Version Number

5

DI Record Publish Date

January 06, 2017

Package DI Number

10851607003058

Quantity per Package

1

Contains DI Package

00851607003051

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipper