Catalog Number

-

Brand Name

NA

Version/Model Number

AM-EB-LF2118

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K012444

Product Code

DXQ

Product Code Name

Blood Pressure Cuff

Public Device Record Key

37ef7a9c-b840-4479-adf7-32ee0d3d419e

Public Version Date

February 22, 2019

Public Version Number

1

DI Record Publish Date

January 22, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-