Catalog Number

05-283-023

Brand Name

MABIS

Version/Model Number

05-283-023

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 01, 2018

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)

-

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

2c742a01-7334-4617-932a-689c797a7ae2

Public Version Date

December 14, 2020

Public Version Number

5

DI Record Publish Date

September 23, 2016

Package DI Number

10767056830230

Quantity per Package

50

Contains DI Package

00767056830233

Package Discontinue Date

July 01, 2018

Package Status

Not in Commercial Distribution

Package Type

Master Carton