Catalog Number

43664

Brand Name

Hokanson

Version/Model Number

43664

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K041689

Product Code

DXQ

Product Code Name

Blood Pressure Cuff

Public Device Record Key

8f9d280a-04f9-469d-8452-5d516bcf9bc6

Public Version Date

September 24, 2020

Public Version Number

2

DI Record Publish Date

April 27, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-