Catalog Number

71876

Brand Name

PICC WAND

Version/Model Number

Max Barrier Kit 5Fr

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

OFD

Product Code Name

Catheter Introducer Kit

Public Device Record Key

e433f43b-48dd-495f-b27a-217ab92c8ed9

Public Version Date

June 07, 2019

Public Version Number

3

DI Record Publish Date

September 09, 2016

Package DI Number

20859821006401

Quantity per Package

10

Contains DI Package

10859821006404

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton