Catalog Number

-

Brand Name

Radius PPG

Version/Model Number

4589

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

-

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

MWI

Product Code Name

Monitor, physiological, patient (without arrhythmia detection or alarms)

Public Device Record Key

66f70b04-c068-426e-bd69-8ec514bf63bf

Public Version Date

October 18, 2021

Public Version Number

1

DI Record Publish Date

October 08, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-