Catalog Number

01-140-011

Brand Name

MABIS

Version/Model Number

01-140-011

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)

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

K942543,K942543

Product Code

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Public Device Record Key

0e458bc0-176b-488e-b044-5719c9dea340

Public Version Date

December 14, 2020

Public Version Number

3

DI Record Publish Date

September 23, 2016

Package DI Number

10767056400112

Quantity per Package

50

Contains DI Package

00767056400115

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master Carton