Catalog Number

-

Brand Name

Med-link

Version/Model Number

Y000DSN1-1#

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

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K160530,K160530,K160530

Product Code

DXQ

Product Code Name

Blood Pressure Cuff

Public Device Record Key

1af5210d-77c4-4a6f-84df-54cdca464d11

Public Version Date

March 27, 2020

Public Version Number

4

DI Record Publish Date

March 30, 2017

Package DI Number

16944414036259

Quantity per Package

24

Contains DI Package

06944414036252

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box