Catalog Number

PT-INF-T

Brand Name

PSI-TEC Infiltration Tubing

Version/Model Number

PT-INF-T

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

KGZ

Product Code Name

ACCESSORIES, CATHETER

Public Device Record Key

74173366-8826-49c0-b6ea-f2f52569914b

Public Version Date

April 23, 2019

Public Version Number

4

DI Record Publish Date

September 14, 2016

Package DI Number

10081317023330

Quantity per Package

10

Contains DI Package

00081317023333

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

10 Pouches/Box