Catalog Number

689721/B

Brand Name

Safedraw™

Version/Model Number

10884450544157

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

4be3422b-81a6-472d-a817-0e2f082e5865

Public Version Date

December 13, 2021

Public Version Number

2

DI Record Publish Date

January 27, 2021

Package DI Number

20884450544154

Quantity per Package

4

Contains DI Package

10884450544157

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-