Catalog Number

384171

Brand Name

First PICC™ S/L Peripherally Inserted Central Catheter Basic Kit

Version/Model Number

384171

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

K972262,K972262

Product Code

FOZ

Product Code Name

Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days

Public Device Record Key

e603d1c8-0c2e-4892-94dd-ecf7a3bcd4e1

Public Version Date

February 19, 2021

Public Version Number

4

DI Record Publish Date

September 21, 2016

Package DI Number

20886333209716

Quantity per Package

5

Contains DI Package

00886333209712

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box