Catalog Number

-

Brand Name

IMCO

Version/Model Number

840-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

271b8a3b-fbad-4978-9425-0b977b344afe

Public Version Date

July 22, 2019

Public Version Number

3

DI Record Publish Date

June 10, 2016

Package DI Number

10815842023080

Quantity per Package

15

Contains DI Package

00815842023083

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case