Catalog Number

-

Brand Name

HydroPICC

Version/Model Number

PICC-141

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 26, 2020

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

LJS

Product Code Name

Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days

Public Device Record Key

6edc8be8-cfff-449d-ad89-d72e23559700

Public Version Date

February 19, 2021

Public Version Number

3

DI Record Publish Date

October 15, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-