Catalog Number

689844/B

Brand Name

Safedraw™

Version/Model Number

10884450619299

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

af76af77-981c-4c98-bc63-56ff4e1f228c

Public Version Date

March 08, 2022

Public Version Number

1

DI Record Publish Date

February 28, 2022

Package DI Number

20884450619296

Quantity per Package

4

Contains DI Package

10884450619299

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-