Catalog Number

-

Brand Name

Portex

Version/Model Number

100/465/060CZ

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

BWC

Product Code Name

Needle, emergency airway

Public Device Record Key

ada86ee5-ff99-45a2-846d-43536b57e302

Public Version Date

June 24, 2019

Public Version Number

6

DI Record Publish Date

May 29, 2017

Package DI Number

35019315110522

Quantity per Package

1

Contains DI Package

15019315110528

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX