Catalog Number

689361/B

Brand Name

Safedraw™

Version/Model Number

10884450385101

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

DSK

Product Code Name

COMPUTER, BLOOD-PRESSURE

Public Device Record Key

773f13d0-fedc-4bc9-b8c2-7d0147cb03de

Public Version Date

December 13, 2021

Public Version Number

2

DI Record Publish Date

August 08, 2019

Package DI Number

20884450385108

Quantity per Package

5

Contains DI Package

10884450385101

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-