Catalog Number

RMD-002

Brand Name

mcompass Biofeedback Manometry System

Version/Model Number

RMD-002

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

K143031,K143031

Product Code

HCC

Product Code Name

Device, Biofeedback

Public Device Record Key

094ab41d-1477-46d1-8044-2b20f688b370

Public Version Date

November 08, 2019

Public Version Number

5

DI Record Publish Date

January 06, 2017

Package DI Number

10851607003065

Quantity per Package

1

Contains DI Package

00851607003068

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipper