Catalog Number

-

Brand Name

Equate

Version/Model Number

570996286

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

K193259

Product Code

DXQ

Product Code Name

Blood Pressure Cuff

Public Device Record Key

650751cd-0a9d-44de-bce4-d651b3458353

Public Version Date

November 06, 2020

Public Version Number

1

DI Record Publish Date

October 29, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-