Catalog Number

-

Brand Name

Portex

Version/Model Number

66-1997

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

-

Product Code

BZA

Product Code Name

CONNECTOR, AIRWAY (EXTENSION)

Public Device Record Key

af31de35-48f9-4795-b868-2bd46a681463

Public Version Date

October 21, 2020

Public Version Number

4

DI Record Publish Date

July 02, 2018

Package DI Number

50788942619973

Quantity per Package

50

Contains DI Package

10788942619975

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE