Catalog Number

-

Brand Name

Portex

Version/Model Number

197-37R

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

K953483,K953483,K953483

Product Code

CBI

Product Code Name

TUBE, TRACHEAL/BRONCHIAL, DIFFERENTIAL VENTILATION (W/WO CONNECTOR)

Public Device Record Key

4e1839c4-a83a-4bec-a195-5a3166f92d89

Public Version Date

October 08, 2018

Public Version Number

4

DI Record Publish Date

September 01, 2015

Package DI Number

55019315058569

Quantity per Package

8

Contains DI Package

35019315058565

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case