Catalog Number

8650-11AL

Brand Name

Adcuff™

Version/Model Number

8650-11AL

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"

-

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

5599e572-f7b6-4e7d-baf8-73ea789e2ea1

Public Version Date

July 22, 2019

Public Version Number

2

DI Record Publish Date

May 04, 2018

Package DI Number

00634782586454

Quantity per Package

20

Contains DI Package

00634782886455

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master Case