Catalog Number

850CN-1

Brand Name

Adcuff™

Version/Model Number

850CN-1

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 15, 2019

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)

Yes

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

7cba7c9d-919b-4d9b-b5a1-f0cea571c4a2

Public Version Date

July 22, 2019

Public Version Number

4

DI Record Publish Date

September 21, 2016

Package DI Number

00634782538934

Quantity per Package

15

Contains DI Package

00634782039103

Package Discontinue Date

April 15, 2019

Package Status

Not in Commercial Distribution

Package Type

Master Case