Catalog Number

1294.13

Brand Name

Lifecath PICC PUR

Version/Model Number

1294.13

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

LJS

Product Code Name

Catheter,intravascular,therapeutic,long-term greater than 30 days

Public Device Record Key

f3c63b84-12c6-44f4-8c2f-80135ac2cbbe

Public Version Date

February 19, 2021

Public Version Number

5

DI Record Publish Date

October 27, 2015

Package DI Number

53660812012268

Quantity per Package

10

Contains DI Package

03660812012263

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-