Catalog Number

-

Brand Name

Portex

Version/Model Number

Z210-12

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

BSY

Product Code Name

CATHETERS, SUCTION, TRACHEOBRONCHIAL

Public Device Record Key

adeae916-b11a-4f1b-9202-561199bff412

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

October 19, 2016

Package DI Number

35019315046890

Quantity per Package

20

Contains DI Package

15019315046896

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CARTON