Catalog Number

WUSA/COMBO

Brand Name

Wilburn Medical USA

Version/Model Number

WUSA/COMBO

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

-

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

8f49279f-e20a-4970-97be-c5a6c06eaa95

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

April 11, 2017

Package DI Number

50628725004452

Quantity per Package

50

Contains DI Package

00628725004457

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-