Catalog Number

M000003

Brand Name

StatLock Pro

Version/Model Number

M000003

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

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

Yes

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

-

FDA Premarket Submission

-

Product Code

FPA

Product Code Name

Set, administration, intravascular

Public Device Record Key

c0c97f01-0f72-48b4-89b0-8c8acf1438fc

Public Version Date

April 09, 2019

Public Version Number

1

DI Record Publish Date

April 01, 2019

Package DI Number

10801741148726

Quantity per Package

30

Contains DI Package

00801741148729

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA