Catalog Number

-

Brand Name

MumEase

Version/Model Number

AB1

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K193374

Product Code

MVV

Product Code Name

Device, Acupressure

Public Device Record Key

778e1fb8-b0ca-465d-bd49-f5d0d5fe2ff3

Public Version Date

April 17, 2020

Public Version Number

1

DI Record Publish Date

April 09, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-