Catalog Number

5279864

Brand Name

LEADER

Version/Model Number

5279864

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

-

Product Code

DXN

Product Code Name

SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE

Public Device Record Key

a5a6b59f-9134-40cd-bbee-c5460a60ff8f

Public Version Date

July 02, 2021

Public Version Number

4

DI Record Publish Date

May 09, 2017

Package DI Number

50096295129293

Quantity per Package

12

Contains DI Package

00096295129298

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE