Catalog Number

-

Brand Name

IMCO

Version/Model Number

802-IMC

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

DXQ

Product Code Name

Blood Pressure Cuff

Public Device Record Key

71cc2f1c-5d7c-48a2-a7b2-a5d1867a11be

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

June 10, 2016

Package DI Number

10815842023066

Quantity per Package

12

Contains DI Package

00815842023069

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case