Catalog Number

-

Brand Name

MonitorMe

Version/Model Number

MM1250

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 30, 2021

Issuing Agency

In HIBCC

MRI safety Status

MR Unsafe

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

Yes

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

-

Product Code

DRG

Product Code Name

Transmitters And Receivers, Physiological Signal, Radiofrequency

Public Device Record Key

271417b9-6cc2-42f3-b476-678d9f89346c

Public Version Date

April 13, 2022

Public Version Number

4

DI Record Publish Date

December 14, 2020

Package DI Number

B353MM12502

Quantity per Package

25

Contains DI Package

B353MM12501

Package Discontinue Date

April 30, 2021

Package Status

Not in Commercial Distribution

Package Type

Small box