Catalog Number

RMD-002-004

Brand Name

mcompass Biofeedback 2-Channel Catheter

Version/Model Number

RMD-002-004

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"

Yes

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

K143031,K143031,K143031

Product Code

HCC

Product Code Name

Device, Biofeedback

Public Device Record Key

0ed8f134-869d-4d66-802c-c36e63ba910b

Public Version Date

November 08, 2019

Public Version Number

5

DI Record Publish Date

January 06, 2017

Package DI Number

20851607003079

Quantity per Package

4

Contains DI Package

10851607003072

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipper