Catalog Number

-

Brand Name

Pertrach

Version/Model Number

301-D4557

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

K914743,K914743

Product Code

BTO

Product Code Name

Tube, Tracheostomy (W/Wo Connector)

Public Device Record Key

e7130fdb-2e31-4374-9f3e-5ea7a4176bd9

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

May 27, 2016

Package DI Number

10841470104310

Quantity per Package

5

Contains DI Package

00841470104313

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-