Catalog Number

-

Brand Name

NONE

Version/Model Number

AS-ND

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

K082542,K082542

Product Code

DXQ

Product Code Name

Blood Pressure Cuff

Public Device Record Key

2fe556bd-2707-4b3c-918d-4095965be7e5

Public Version Date

October 03, 2019

Public Version Number

1

DI Record Publish Date

September 25, 2019

Package DI Number

26970366970072

Quantity per Package

50

Contains DI Package

06970366970078

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

MASTER CARTON