Catalog Number

-

Brand Name

EXANOVO

Version/Model Number

MC-20A

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)

Yes

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

K203620

Product Code

DXQ

Product Code Name

Blood Pressure Cuff

Public Device Record Key

3c979568-dc00-4863-b343-e34b6b791d02

Public Version Date

May 17, 2021

Public Version Number

1

DI Record Publish Date

May 08, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-