Catalog Number

4002500

Brand Name

PALA-NATE

Version/Model Number

Medium

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K923591,K923591

Product Code

BTR

Product Code Name

Tube, Tracheal (W/Wo Connector)

Public Device Record Key

d505ff0a-e52f-48fb-a92b-4e6e324983ec

Public Version Date

December 18, 2019

Public Version Number

5

DI Record Publish Date

September 23, 2016

Package DI Number

H67140025001

Quantity per Package

10

Contains DI Package

H67140025000

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box