Catalog Number

-

Brand Name

SoftCheck

Version/Model Number

ST2635FL

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K940214,K940214

Product Code

DXQ

Product Code Name

Blood Pressure Cuff

Public Device Record Key

4abc209b-4075-4bcd-8242-cf8b798aa3d5

Public Version Date

September 09, 2019

Public Version Number

1

DI Record Publish Date

August 30, 2019

Package DI Number

10858293006578

Quantity per Package

5

Contains DI Package

00858293006571

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Bag