Catalog Number

/

Brand Name

heal force

Version/Model Number

B07

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

K200437,K200437

Product Code

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Public Device Record Key

328cb972-b009-49e1-8106-708b256f47d4

Public Version Date

November 23, 2021

Public Version Number

1

DI Record Publish Date

November 15, 2021

Package DI Number

16927709465101

Quantity per Package

30

Contains DI Package

06927709465104

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton