Catalog Number

768-619-11ATLKIT

Brand Name

Pro's Combo™

Version/Model Number

768-619-11ATLKIT

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

919e6e92-a78e-48b8-9486-b1d55d62ac55

Public Version Date

August 09, 2021

Public Version Number

1

DI Record Publish Date

July 30, 2021

Package DI Number

00634782599362

Quantity per Package

3

Contains DI Package

00634782097981

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master Case