Catalog Number

8451-10SARB-1HP

Brand Name

Adcuff™

Version/Model Number

8451-10SARB-1HP

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)

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

f9d1862c-bb92-40dd-9eb1-937bc1957160

Public Version Date

August 10, 2020

Public Version Number

1

DI Record Publish Date

July 31, 2020

Package DI Number

00634782599454

Quantity per Package

15

Contains DI Package

00634782098070

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master Case