Catalog Number

-

Brand Name

Paradigm® REAL-Time Revel™

Version/Model Number

MMT-723KNS

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

P980022

Product Code

MDS

Product Code Name

Sensor, glucose, invasive

Public Device Record Key

34bcb8af-258b-4d7a-a840-e4152e43db66

Public Version Date

October 31, 2018

Public Version Number

1

DI Record Publish Date

September 30, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-