Catalog Number

-

Brand Name

LabTron

Version/Model Number

180X

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

Yes

Device labeled as "Not made with natural rubber latex"

-

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

K092245,K092245

Product Code

DXQ

Product Code Name

Blood Pressure Cuff

Public Device Record Key

1373506e-04e5-47de-a869-342a8089b0c9

Public Version Date

July 25, 2019

Public Version Number

4

DI Record Publish Date

August 31, 2016

Package DI Number

M368180X2

Quantity per Package

24

Contains DI Package

M368180X1

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-