Catalog Number

688062/B

Brand Name

Safedraw™

Version/Model Number

10884450372781

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

DXN

Product Code Name

System, measurement, blood-pressure, non-invasive

Public Device Record Key

690e22d5-5f6d-421d-9634-473b1b195fe5

Public Version Date

December 13, 2021

Public Version Number

2

DI Record Publish Date

July 21, 2021

Package DI Number

20884450372788

Quantity per Package

4

Contains DI Package

10884450372781

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-