Catalog Number

-

Brand Name

Medspira mcompass Anorectal Manometry Dock for Tablet PC, w/Power Supply

Version/Model Number

RMD-010-004

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"

-

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

K143031,K143031

Product Code

KLA

Product Code Name

Monitor, Esophageal Motility, Anorectal Motility, And Tube

Public Device Record Key

d3d217eb-1320-40be-b1f5-119ff2993e6a

Public Version Date

February 14, 2022

Public Version Number

1

DI Record Publish Date

February 04, 2022

Package DI Number

10851607003317

Quantity per Package

1

Contains DI Package

00851607003310

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipper